ALINITY I B12 REAGENT KIT
Received Sep 18, 2023 · Event occurred Sep 7, 2023
Report 3005094123-2023-00248 · MDR key 17766252
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P67-32
Lot number
49132UD00
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 I B12 RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE: 140 TO 650 PMOL/L): SID (B)(6) INITIAL RESULT = 325 PMOL/L, REPEAT = 220 PMOL/L. 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, LONGFORD TO ALINITY I PROCESSING MODULE, 03R65-01, IRVING IA/CC. MDR NUMBER 3016438761-2023-00586-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER. SECTION G1 HAS BEEN UPDATED TO CURRENT CONTACT INFORMATION. H3 OTHER TEXT : AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I B12 REAGENT KIT, LIST NUMBER 07P67-32, LONGFORD TO ALINITY I PROCESSING MODULE, 03R65-01, IRVING IA/CC. MDR NUMBER 3016438761-2023-00586-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I B12 RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE: 140 TO 650 PMOL/L): SID (B)(6) INITIAL RESULT = 325 PMOL/L, REPEAT = 220 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P67-32 HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P67-21/-31.