LACTATE DEHYDROGENASE
Received Jun 11, 2017 · Event occurred May 23, 2017
Report 1415939-2017-00132 · MDR key 6632880
Device
Generic name
Lactate Dehydrogenase,
Manufacturer
Abbott LaboratoriesCatalog number
02P56-41
Lot number
80712UN16
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
ON MARCH 22, 2019 IT WAS IDENTIFIED THAT: THE INCORRECT MANUFACTURING LOCATION WAS DOCUMENTED UNDER THIS MANUFACTURER REPORT NUMBER (1415939-2017-00132). A NEW MANUFACTURER REPORT (NUMBER 1628664-2019-00247) HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.
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 OBSERVED FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULTS WHILE USING THE CLINICAL CHEMISTRY LDH ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS: INITIAL 1046, THIS RESULT WAS QUESTIONED BY THE PHYSICIAN AND TESTING WAS REPEATED RETESTS: 187 AND 192. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, AN INSTRUMENT LOG REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE INSTRUMENT LOG REVIEW INDICATED THAT THE ANALYZER HAD GENERATED ERROR CODES TO INDICATE THAT ASPIRATION ERRORS HAD OCCURRED. ADDITIONALLY, IT INDICATED THAT PREVENTATIVE MAINTENANCE WAS NOT PERFORMED (CLEAN CUVETTES) IN MAY 2017. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND FOR ISSUE OBSERVED BY THE CUSTOMER. NO OTHER SIMILAR COMPLAINTS WERE IDENTIFIED WITH THIS REAGENT LOT NUMBER. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO DEFICIENCY OF THE CLINICAL CHEMISTRY LDH ASSAY, REAGENT LIST NUMBER 02P56, LOT 80712UN16, WAS IDENTIFIED.