ADVIA CHEMISTRY CONCENTRATED ALANINE AMINOTRANSFERASE (ALT_C) REAGENT

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2432235-2023-00178 ON 22-JUN-2023. ADDITIONAL INFORMATION (22-JUN-2023): A SAMPLE SPECIFIC ISSUE DUE TO POTENTIAL INTERFERENT POTENTIALLY CONTRIBUTED TO THE VARIABLE ALANINE AMINOTRANSFERASE (ALT) RESULTS. THE SAMPLE WAS NOT AVAILABLE FOR FURTHER TESTING, SO FURTHER TESTING OF THE SAMPLE COULD NOT BE PERFORMED. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. MDR 2432235-2023-00179 AND THE ASSOCIATED SUPPLEMENTAL REPORT PERTAINS TO THE SAME PATIENT.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT VARIABLE ALANINE AMINOTRANSFERASE (ALT) RESULTS OBTAINED ON A PATIENT SAMPLE ON TWO ADVIA CHEMISTRY XPT INSTRUMENTS (IDENTIFIED AS CA1275001960196 AND CA1275001970197) USING ADVIA CHEMISTRY CONCENTRATED ALANINE AMINOTRANSFERASE (ALT_C) REAGENT. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. QUALITY CONTROLS FOR ALL METHODS WERE ACCEPTABLE BEFORE AND AFTER THIS SAMPLE WAS PROCESSED. A SIEMENS CUSTOMER SERVICE ENGINEER EVALUATED THE INSTRUMENT BY RUNNING SAMPLES WITH HIGH ALT CONCENTRATION AND THE RESULTS RECOVERED AS EXPECTED. THEN, THE CSE ALSO RAN SAMPLES WITH LOW ALT CONCENTRATION, AND THERE WERE NO DISCREPANT RESULTS. THE CUSTOMER ALSO INDICATED FLAGS WERE NOT TRIGGERED ON OTHER SAMPLES PROCESSED AT THE TIME OF THE EVENT AND THE CUSTOMER WAS REPORTING ALT RESULTS FOR OTHER PATIENTS DURING THIS TIME. SIEMENS MEDICAL AFFAIRS ASSESSED THE EVENT AND DETERMINED IT IS UNCLEAR WHY THE FIRST OBTAINED ALT RESULT WITHOUT ASSOCIATED ERROR MESSAGE AT 11:34 PM ON (B)(6) 2023 OF 27.8 U/L WAS QUESTIONED, INITIATED REPEAT TESTING, AND DELAYED RESULT REPORTING. THE ACCEPTED ALT RESULT AT 02:36 AM ON (B)(6) 2023 OF 39.2 U/L WAS WITHIN THE REFERENCE RANGE AND IS NOT CONSIDERED CLINICALLY CRITICAL. FURTHERMORE, THERE IS NO EVIDENCE OR INDICATION THAT THE ALT RESULT WAS NECESSARY FOR THE INITIATION OF TREATMENT. ADDITIONALLY, FROM THE DATA PROVIDED, THE CUSTOMER INDICATED THAT THE OTHER TEST RESULTS, SUCH AS UREA NITROGEN AND CREATININE, WERE NOT DISCORDANT. IT IS UNCLEAR AT THIS TIME WHY THE OTHER VALID AND ACCURATE LABORATORY RESULTS (OTHER THAN ALT) WERE NOT MADE AVAILABLE TO THE MEDICAL TEAM WITHOUT DELAY. ALTHOUGH THE WITHHELD CREATININE AND UREA NITROGEN RESULTS BY THE LAB WERE ELEVATED AND INDICATING KIDNEY FAILURE, IN AN URGENT, CRITICAL CARE SETTING, A LIFE-THREATENING CONDITION IS TREATED BASED ON THE CLINICAL SYMPTOMS AND THE AVAILABLE CLINICAL AND LABORATORY MEDICAL INFORMATION. ALSO, FOR A PATIENT IN A MEDICAL EMERGENCY WHO IS DETERIORATING CLINICALLY, CLINICAL DECISIONS AND URGENT TREATMENT WOULD BE PERFORMED BASED OFF THE CLINICAL CONDITION OF THE PATIENT, IN ACCORDANCE WITH GOOD CLINICAL PRACTICE. MOREOVER, ACCORDING TO GOOD LABORATORY AND CLINICAL PRACTICE, TURNAROUND TIME (TAT) OF ALL SAMPLES, ESPECIALLY ANY EMERGENCY OR STAT SAMPLES OR SPECIMEN ORDERS WOULD GENERALLY BE CLOSELY MONITORED BY THE LABORATORY AND THE TREATING PHYSICIAN. TAT MONITORING IS DONE TO ENSURE PROMPT PATIENT CARE AS REQUIRED BY THE CLINICAL SETTING. ADDITIONALLY, PLANNED AND UNPLANNED DOWNTIMES FOR AN INSTRUMENT ARE USUALLY ANTICIPATED BY A LAB AND PROCEDURES WOULD BE IN PLACE TO ENSURE CONTINUED SAMPLE TESTING. THE DELAY IS BE APPARENT TO THE CUSTOMER, AND ACCORDING TO GOOD LABORATORY PRACTICE, THE DELAY SHOULD BE MITIGATED BY STANDARD POLICIES AND PROCEDURES THAT WOULD BE IN PLACE TO ENSURE UNINTERRUPTED PATIENT CARE. IN EMERGENCY CARE SITUATIONS, LAB RESULTS CAN BE COMMUNICATED OVER THE PHONE UPON PHYSICIAN REQUEST AS IT IS ACCEPTED AND COMMON CLINICAL PRACTICE FOR THE WAITING MEDICAL TEAM TO REACH OUT TO THE LABORATORY TO REQUEST THE STATUS OF A DIRE TEST RESULT AS IT MAY BE NEEDED FOR TREATMENT INITIATION. MITIGATIONS WOULD INCLUDE PROCESSING THE SAMPLE ON A BACKUP INSTRUMENT UNTIL THE ISSUE IS RESOLVED AS IT WAS DONE IN THIS CASE. PATIENT TREATMENT WOULD NOT BE BASED OFF A SINGLE SERUM CREATININE/UREA NITROGEN/ALT RESULT BUT WOULD BE CORRELATED WITH PATIENT¿S CLINICAL SIGNS AND SYMPTOMS, URINE OUTPUT AND OTHER PARAMETERS. LASTLY THE ICTERUS INTERFERENCE INDEX OF 14, DOES NOT COMPROMISE THE RESULT INTEGRITY OF UREA NITROGEN AND CREATININE, AND THEREFORE, DOES NOT JUSTIFY THE DELAY IN RESULT REPORTING. HENCE, THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION.

Description of Event or Problem

THE CUSTOMER ALLEGED THAT DUE TO VARIABLE ALANINE AMINOTRANSFERASE (ALT) RESULTS OBTAINED ON A PATIENT SAMPLE ON TWO ADVIA CHEMISTRY XPT INSTRUMENTS (IDENTIFIED AS CA1275001960196 AND CA1275001970197) USING ADVIA CHEMISTRY CONCENTRATED ALANINE AMINOTRANSFERASE (ALT_C) REAGENT, THE CUSTOMER DELAYED REPORTING OTHER TESTS ORDERED ON THE SAMPLE; THE CLINICIAN ALLEGED THE DELAY IN REPORTING RESULTS WAS A FACTOR THAT AFFECTED THE CARE OF A CLINICALLY DETERIORATING PATIENT. THE LABORATORY WAS RELEASING RESULTS FOR OTHER PATIENTS DURING THIS TIME. THE CUSTOMER REPORTED THAT AT THE TIME OF THE EVENT, BLOOD GAS RESULTS FROM ANOTHER INSTRUMENT WERE AVAILABLE TO THE CLINICIAN AND CALCIUM/MAGNESIUM AND SALINE IV WERE UNDERWAY. SINCE THE CUSTOMER DID NOT RELEASE THE UREA NITROGEN AND CREATININE RESULTS, THE CLINICIAN DID NOT HAVE THESE RESULTS FROM THE ADVIA CHEMISTRY XPT INSTRUMENTS. IT IS UNKNOWN WHY THE LABORATORY DID NOT PROMPTLY RELEASE THE RESULTS TO THE CLINICIANS. THE SAMPLE WAS COLLECTED AT 11:00 PM ON (B)(6) 2023 AND ARRIVED AT THE LABORATORY AT 11:03 PM ON (B)(6) 2023. THE UNFLAGGED RESULTS FOR ALL THREE ANALYTES, ALT, UREA NITROGEN AND CREATININE, WERE AVAILABLE AT 11:34 PM ON (B)(6) 2023. THE PATIENT EXPIRED AT 1:43 AM ON (B)(6) 2023. THE HEALTH CARE PROVIDER DID NOT STATE A CAUSAL RELATIONSHIP BETWEEN THE DELAY IN RECEIVING RESULTS FROM THE LABORATORY AND THE PATIENT EXPIRING. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.