ALINITY C LACTATE DEHYDROGENASE REAGENT KIT
Received Dec 8, 2020 · Event occurred Nov 18, 2020
Report 3002809144-2020-01166 · MDR key 10970156
Device
Generic name
Nad Reduction/nadh Oxidation, Lactate Dehydrogenase
Manufacturer
Abbott GmbhModel number
07P7430Catalog number
07P74-30
Lot number
83390UN20
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
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 LDH RESULTS GENERATED ON THE ALINITY C ANALYZER ON MULTIPLE PATIENTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
A REVIEW OF TICKETS DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR ALINITY C LACTATE DEHYDROGENASE (LDH) REAGENT LIST NUMBER 07P74-30, LOT NUMBER 83390UN20. TRENDING REVIEW DETERMINED NO TRENDS FOR FALSELY ELEVATED RESULTS FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. THE SEARCH DID NOT SHOW ANY RELATED POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY C LACTATE DEHYDROGENASE (LDH) REAGENT LIST NUMBER 07P74-30, LOT NUMBER 83390UN20.