ALINITY I B12 REAGENT KIT
Received Jul 6, 2023 · Event occurred Jun 19, 2023
Report 3005094123-2023-00169 · MDR key 17267459
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P67-32
Lot number
50558UD00
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
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I B12 RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT 115.1 PMOL/L (LOT 47142UD00) REPEATED 241.7 PMOL/L (LOT 50558UD00) AND 145.0 PMOL/L (LOT 50558UD00). THE CUSTOMER BELIEVES THAT 115.1 AND 145.0 PMOL/L ARE THE CORRECT RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I B12 RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT 115.1 PMOL/L (LOT 47142UD00). REPEATED 241.7 PMOL/L (LOT 50558UD00) AND 145.0 PMOL/L (LOT 50558UD00). THE CUSTOMER BELIEVES THAT 115.1 AND 145.0 PMOL/L ARE THE CORRECT RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I B12 REAGENT KIT, LIST NUMBER 07P67-32, ABBOTT IRELAND DIAGNOSTICS DIVISION, LISNAMUCK, LONGFORD, IRELAND, N39E932 TO ALINITY I PROCESSING MODULE, LIST NUMBER 03R65-01, ABBOTT LABORATORIES, 1915 HURD DRIVE, IRVING, TX, 75038. MDR NUMBER 3016438761-2023-00462 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER. H3 OTHER TEXT : AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I B12 REAGENT KIT, LIST NUMBER 07P67-32, TO ALINTY I PROCESSING MODULE, LIST NUMBER 03R65-01. MDR NUMBER 3016438761-2023-00462 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.