LACTATE DEHYDROGENASE (LDH)

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED LDH RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE (SN (B)(4) FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). INITIAL RESULT (SN (B)(4) 295 U/L, REPEATED ON ANOTHER INSTRUMENT (SN (B)(4) 683 AND 979 U/L SAME SAMPLE REPEATED AGAIN ON (C1601491) 303 AND 314 U/L, REPEATED ON (SN (B)(4) 309 U/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

PATIENT IDENTIFIER: SID (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Additional Manufacturer Narrative

DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE LOT SEARCH REVIEW DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ISSUE. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT 91126UN21, WHICH DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. LABELING IS ADEQUATE INFORMATION FOR THE OPERATOR TO PREPARE SAMPLES FOR LDH ANALYSIS. USE ERROR MAY HAVE CONTRIBUTED TO THE CUSTOMER¿S ISSUE AS SAMPLE PREPARATION IS EXTENSIVELY COVERED IN THE INSTRUCTIONS FOR USE. LOG ANALYSIS SHOWS SAMPLE PREPARATION MAY BE THE MOST LIKELY CAUSE. BASED ON ALL REVIEWED DATA, WE CONCLUDE THAT THERE IS NO PRODUCT DEFICIENCY WITH THE LDH REAGENT IDENTIFIED IN THIS COMPLAINT.