ALINITY LACTATE DEHYDROGENASE2
Received Oct 3, 2022 · Event occurred Sep 20, 2022
Report 3005094123-2022-00210 · MDR key 15528642
Device
Generic name
Nad Reduction/nadh Oxidation, Lactate Dehydrogenase
Manufacturer
A.i.d.d LongfordCatalog number
04T99-30
Lot number
39506UD00
Product problems
- High Test Results
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C LDH RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: 125-220 U/L): AC01723. (B)(6) 2022, (B)(6) LDH2 535 U/L (HIGH), REPEATED ON ANOTHER INSTRUMENT (DATA NOT AVAILABLE) (B)(6) 2022, (B)(6) LDH2 476 U/L (HIGH), REPEATED ON ANOTHER INSTRUMENT (DATA NOT AVAILABLE) TWO ADDITIONAL SIDS WERE PROVIDED ((B)(6)), HOWEVER, NO VALUES WERE PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
PATIENT IDENTIFIER: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Additional Manufacturer Narrative
THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT 39506UD00, WHICH DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. LABELLING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. IN HOUSE ACCURACY TESTING WAS PERFORMED USING RETAINED REAGENT FILE SAMPLES OF LOT 39506UD00. THE TESTING RESULTS MET ACCEPTANCE CRITERIA AND THE PRODUCT IS PERFORMING AS EXPECTED. BASED ON ALL REVIEWED DATA, WE CONCLUDE THAT THERE IS NO PRODUCT DEFICIENCY WITH THE ALINITY LACTATE DEHYDROGENASE2 REAGENT IDENTIFIED IN THIS COMPLAINT.CORRECTED INFORMATION FOUND IN SECTION D4. CATALOGUE NUMBER CHANGED TO 04T99-30.