CLIN CHEM LDH

Additional Manufacturer Narrative

PATIENT ID CONTAINS TOO MANY CHARACTERS TO FIT IN THE PATIENT IDENTIFIER FIELD: (B)(6) AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER STATED THAT AN ELEVATED LDH RESULT OF 910 U/L WAS GENERATED. THE SAMPLE WAS REPEATED IN DUPLICATE AND RESULTS OF 198 AND 202 U/L WERE GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

NO PATIENT SAMPLE WAS AVAILABLE FOR INVESTIGATION. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE OR NON-STATISTICAL TRENDS WERE IDENTIFIED. A REVIEW FOR NON-CONFORMANCES, PNCRS, OR DEVIATIONS WAS PERFORMED FOR THE CLINICAL CHEMISTRY LDH REAGENT AND NONE WERE IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE CLINICAL CHEMISTRY LDH REAGENT PACKAGE INSERT WERE REVIEWED AND WERE FOUND TO ADEQUATELY ADDRESS THE ISSUE. IN ADDITION TECHNICAL BULLETIN 1005-2013 REV 05 STATES ABBOTT HAS RECEIVED NUMEROUS COMPLAINTS REGARDING INCORRECT PATIENT RESULTS FOR MULTIPLE REAGENTS THAT ARE NOT DUE TO REAGENT DEFICIENCIES. CUSTOMERS MUST FOLLOW MANUFACTURER'S INSTRUCTIONS FOR BOTH TUBES AND CENTRIFUGES. SERUM AND PLASMA SAMPLES, IF NOT SPUN ACCORDING TO MANUFACTURER'S SPECIFICATIONS, MAY GENERATE INACCURATE VALUES. IF A CUSTOMER SUSPECTS INCORRECT RESULTS HAVE BEEN GENERATED, ENSURE THEY HAVE FOLLOWED MANUFACTURER'S SPECIFICATIONS FOR BOTH TUBES AND THE CENTRIFUGE. IF NOT, THEY SHOULD RE-RUN THE SAMPLE AFTER MANUFACTURER'S SPECIFICATIONS HAVE BEEN FOLLOWED. NORMAL INSTRUMENT TROUBLESHOOTING SHOULD ALSO BE PERFORMED. IT IS CRITICAL THAT SPIN TIMES ARE NOT REDUCED AS COMPENSATION FOR HIGHER CENTRIFUGE SPEEDS. A CUSTOMER LETTER SUMMARIZING THE TB IS ATTACHED TO THE TB AND MAY BE SENT TO CUSTOMERS AS-NEEDED. THE INSTRUMENT HISTORY AND MAINTENANCE LOGS FROM THE CUSTOMER'S INSTRUMENT SERIAL NUMBER (B)(4) WERE REVIEWED. REVIEW OF THE HISTORY LOG SHOWS 13 OCCURRENCES OF EC 3375 (ASPIRATION ERROR) AND 22 OCCURRENCES OF EC 0550 (INSTRUMENT HARD STOPS) FROM DECEMBER 1, 2016 TO JANUARY 31, 2017. REVIEW OF THE MAINTENANCE LOG SHOWS THE CUSTOMER DID NOT PERFORM AS NEEDED MAINTENANCE (6052) UNTIL AFTER THE DISCREPANT RESULT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

Additional Manufacturer Narrative

THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THEREFORE, THE DEVICE WAS NOT PERFORMING AS INTENDED AT THE CUSTOMER SITE. HOWEVER NO SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS IDENTIFIED.