ARCHITECT LACTATE DEHYDROGENASE2

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT LACTATE DEHYDROGENASE2 AND PROVIDED THE FOLLOWING DATA: REFERENCE RANGE: 125 - 220 U/L. SAMPLE ID #(B)(6). ORIGINAL RESULT: >1465. REPEAT DILUTED: 141.3. REPEATED NEAT AGAIN: 150.7. REPEATED DILUTED: 143.4. IT WAS REPORTED THAT WHEN THE FIELD SERVICE ENGINEER (FSE) INSTALLED THE ASSAY FILE, THE UNDILUTED PROTOCOL WAS SELECTED AND INTEGRATION WAS PERFORMED USING THE UNDILUTED PROTOCOL RATHER THAN THE DILUTED PROTOCOL. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

E1 PHONE: COMPLETE PHONE NUMBER IS (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE COMPLAINT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NO NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES, OR DEVIATIONS WITH THE COMPLAINT LOT. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT LACTATE DEHYDROGENASE2 REAGENT LOT 57160UD00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT LACTATE DEHYDROGENASE2 AND PROVIDED THE FOLLOWING DATA: REFERENCE RANGE: 125 - 220 U/L. SAMPLE ID #(B)(6) ORIGINAL RESULT: >1465 REPEAT DILUTED: 141.3 REPEATED NEAT AGAIN: 150.7 REPEATED DILUTED: 143.4 IT WAS REPORTED THAT WHEN THE FIELD SERVICE ENGINEER (FSE) INSTALLED THE ASSAY FILE, THE UNDILUTED PROTOCOL WAS SELECTED AND INTEGRATION WAS PERFORMED USING THE UNDILUTED PROTOCOL RATHER THAN THE DILUTED PROTOCOL. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.