CLINICAL CHEMISTRY LACTATE DEHYDROGENASE
Received Oct 29, 2018 · Event occurred Oct 11, 2018
Report 1628664-2018-01980 · MDR key 8017113
Device
Generic name
Lactate Dehydrogenase
Manufacturer
Abbott Manufacturing IncCatalog number
02P56-21
Lot number
99549UN18
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 IMPRECISE RESULTS WHILE USING CLINICAL CHEMISTRY LACTATE DEHYDROGENASE REAGENTS. THE FOLLOWING DATA WAS PROVIDED FOR ONE PATIENT. SID (B)(4), SPECIMEN 1 INITIAL (DRAWN IN THE MORNING, TESTED AT 5:00 P.M. USING THE C16000 ANALYZER SN C1601627) 388.6 U/L, REPEAT 182.93 U/L, REPEAT USING C8000 ANALYZER SN (B)(4) 329.32, 179.63 U/L SPECIMEN 2 INITIAL (DRAWN IN THE AFTERNOON, TEST TIME NOT PROVIDED USING THE C16000 ANALYZER SN (B)(4) 173.69 MULTIPLE REPLICATES FOR THE PATIENT RANGED FROM 159.57 TO 181.97 U/L, HOWEVER NO DRAW TIME OR ANALYZER USED WERE PROVIDED. PER THE PRODUCT PACKAGE INSERT, THE REFERENCE RANGE FOR THE ASSAY IS 125 TO 220 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Description of Event or Problem
ADDITIONAL SPECIMEN RESULTS WERE PROVIDED. SID (B)(6), INITIAL: 259.53 U/L, REPEAT: 172.94 U/L.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS.
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM CLINICAL CHEMISTRY LACTATE DEHYDROGENASE REAGENTS TO THE ARCHITECT C16000 ANALYZER. MDR NUMBER 1628664-2018-02200 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.