LACTATE DEHYDROGENASE
Received Mar 12, 2019 · Event occurred Feb 18, 2019
Report 1415939-2019-00014 · MDR key 8411818
Device
Generic name
Lactate Dehydrogenase
Manufacturer
Abbott LaboratoriesCatalog number
02P56-21
Lot number
73199UN18
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. AN EVALUATION IS IN-PROCESS.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSELY ELEVATED LACTATE DEHYGROGENASE (LDH) RESULT WHILE USING THE CLINICAL CHEMISTRY LDH ASSAY. THE CUSTOMER INDICATED THE PATIENT WAS ADMITTED AFTER THE INITIAL RESULT WAS GENERATED. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL 1154, RETEST RESULTS: 214, 209 AND 215 U/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
THE INCORRECT MANUFACTURING LOCATION WAS DOCUMENTED IN MANUFACTURER NAME, CITY AND STATE. PLEASE REFER TO MANUFACTURE REPORT NUMBER 1628664-2019-00286 FOR ALL FURTHER INFORMATION. DEVICE EVALUATED BY MFR: AN EVALUATION IS IN-PROCESS.