CLINICAL CHEMISTRY LACTATE DEHYDROGENASE
Received Dec 28, 2018 · Event occurred Dec 14, 2018
Report 1628664-2018-02201 · MDR key 8203982
Device
Generic name
Lactate Dehydrogenase
Manufacturer
Abbott Manufacturing IncCatalog 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
AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM CLINICAL CHEMISTRY LACTATE DEHYDROGENASE REAGENTS TO THE ARCHITECT C8000 ANALYZER. MDR NUMBER 1628664-2019-00013 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. AN EVALUATION IS IN PROCESS.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED RESULTS WHILE USING CLINICAL CHEMISTRY LACTATE DEHYDROGENASE REAGENTS. THE FOLLOWING DATA WAS PROVIDED FOR ONE PATIENT. SID (B)(6) INITIAL 470.62 U/L, REPEAT USING THE SAME ARCHITECT C8000 ANALYZER SN (B)(4) 191.96 U/L, REPEAT USING ANOTHER ANALYZER (ARCHITECT C16000 SN (B)(4)) 188.46, 188.46 U/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.