LACTATE DEHYDROGENASE
Received Mar 2, 2019 · Event occurred Feb 4, 2019
Report 3002809144-2019-00080 · MDR key 8384765
Device
Generic name
Lactate Dehydrogenase
Manufacturer
Abbott GermanyCatalog number
07P74-20
Lot number
66140UN18
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 FIELD DATA, AND A REVIEW OF LABELING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. NO RETURN PATIENT SAMPLE WAS AVAILABLE. HISTORICAL PERFORMANCE OF THE REAGENT LOT WAS EVALUATED USING WORLD WIDE DATA. THE PATIENT DATA WAS ANALYZED AND WITHIN ESTABLISHED CONTROL LIMITS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY LACTATE DEHYDROGENASE (LD/LDH) RESULTS FOR A SAMPLE WERE GENERATED ON THE ALINITY C ANALYZER. THE CUSTOMER REPORTED THE SAMPLE GENERATED SID (B)(6) INITIAL RESULT OF 4154 U/L, WITH A RETEST RESULT OF 730 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.