LACTATE DEHYDROGENASE (LDH)
Received Dec 22, 2021 · Event occurred Dec 14, 2021
Report 3002809144-2021-00716 · MDR key 13064148
Device
Generic name
Nad Reduction/nadh Oxidation, Lactate Dehydrogenase
Manufacturer
Abbott GmbhModel number
2P56-22Catalog number
02P56-22
Lot number
26340UN21
Product problems
- High Test Results
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COMPLAINT INVESTIGATION FOR A FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULT INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. TRENDING REVIEW DETERMINED NO RELATED TRENDS FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LIST NUMBER AND COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LIST NUMBER WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF LACTATE DEHYDROGENASE (LDH) ASSAY, LOT NUMBER 26340UN21, WAS IDENTIFIED.SECTION G1 - CONTACT OFFICE INFORMATION UPDATED.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSELY ELEVATED LACTATE DEHYDROGENASE RESULT FOR ONE PATIENT ON AN ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT WAS 346.64, REPEATS ON OTHER ANALYZERS WERE 141.08, 142.67, AND 143.09 U/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.