LACTATE DEHYDROGENASE
Received Mar 6, 2020 · Event occurred Feb 23, 2020
Report 1628664-2020-00093 · MDR key 9801967
Device
Generic name
Lactate Dehydrogenase
Manufacturer
Abbott Manufacturing IncModel number
2P56-21Catalog number
02P56-21
Lot number
32174UN19
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
PATIENT INFORMATION: NO FURTHER PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. A REVIEW OF TICKETS WAS PERFORMED FOR REAGENT LOT NUMBER 32174UN19. THE TICKET SEARCH DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE LACTATE DEHYDROGENASE (LDH) FOR LOT 32174UN19 WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) INITIAL RESULT = 1319 U/L, REPEAT = 176 U/L, REFERENCE RANGE = 125 U/L TO 243 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.