LACTATE DEHYDROGENASE
Received Sep 25, 2019 · Event occurred Sep 6, 2019
Report 1628664-2019-00635 · MDR key 9119103
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
INVESTIGATION OF THE CUSTOMER'S ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF MANUFACTURING RECORDS AND LABELING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. REVIEW OF COMPLAINT ACTIVITY DETERMINED THAT THERE WAS NORMAL COMPLAINT ACTIVITY FOR REAGENT LOT 04431UN19. REVIEW OF TRACKING AND TRENDING REPORTS DID NOT IDENTIFY ANY RELATED TRENDS FOR THE ARCHITECT LACTATE DEHYDROGENASE ASSAY. MANUFACTURING DOCUMENTATION FOR THE ASSAY DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. ADDITIONALLY, LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT LACTATE DEHYDROGENASE ASSAY WAS IDENTIFIED.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER: COMPLETE ENTRY = (B)(6). PATIENT INFORMATION: NO FURTHER PATIENT INFORMATION WAS PROVIDED.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT LACTATE DEHYDROGENASE RESULT. SAMPLE ID (B)(6) GENERATED 470 AND RETEST OF 89 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.