LACTATE DEHYDROGENASE
Received Jun 9, 2020 · Event occurred May 18, 2020
Report 3002809144-2020-00454 · MDR key 10132829
Device
Generic name
Lactate Dehydrogenase
Manufacturer
Abbott GmbhModel number
2P56-22Catalog number
02P56-22
Lot number
81139UN19
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. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED DUE TO PRIVACY ISSUES.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULT ON ONE PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: ON (B)(6) 2020 (B)(4) INITIAL = 466U/L / RETEST = 220 AND 206U/L (NORMAL RANGE 125-220U/L). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Additional Manufacturer Narrative
A REVIEW OF TICKETS DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR ARCHITECT LDH REAGENT, LOT 81139UN19. TRENDING REVIEW DETERMINED NO TRENDS FOR DISCREPANT PATIENT RESULTS FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. RETESTING BY THE CUSTOMER OF THE SAMPLE GAVE EXPECTED NORMAL RESULTS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT LDH REAGENT LOT NUMBER 81139UN19 WAS IDENTIFIED.