LACTATE DEHYDROGENASE
Received Sep 23, 2019 · Event occurred Sep 2, 2019
Report 1628664-2019-00629 · MDR key 9106572
Device
Generic name
Lactate Dehydrogenase
Manufacturer
Abbott Manufacturing IncCatalog number
02P56-21
Lot number
04431UN19
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF THE DESIGN HISTORY FILE, REVIEW OF FIELD DATA, AND A REVIEW OF LABELING. NO ADVERSE TREND, NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES, OR DEVIATIONS WERE IDENTIFIED FOR THE CUSTOMER'S ISSUE. NO RETURN PATIENT SAMPLE WAS AVAILABLE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. HISTORICAL PERFORMANCE OF THE REAGENT LOT WAS EVALUATED USING WORLD WIDE DATA. THE PATIENT DATA WAS ANALYZED AND WITHIN EXPECTED LIMITS. ACCURATE AND REPRODUCIBLE RESULTS ARE DEPENDENT UPON PROPERLY FUNCTIONING INSTRUMENTS AND REAGENTS, STORAGE OF PRODUCT AS DIRECTED, AND GOOD LABORATORY TECHNIQUE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.
Additional Manufacturer Narrative
NO SPECIFIC PATIENT INFORMATION PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED LDH RESULTS ON THE ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL 469.01, REPEAT 284.91, 296.18, 294.58 THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.