ALINITY I B12 REAGENT KIT
Received Nov 2, 2023 · Event occurred Oct 3, 2023
Report 3005094123-2023-00296 · MDR key 18061055
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P67-32
Lot number
53664UD00
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 INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LOT NUMBER AND COMPLAINT ISSUE. THE TICKET SEARCH BY LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. REVIEW OF TICKET AND TRENDING CONCLUDED THAT THERE NO TRENDS IDENTIFIED. IN-HOUSE TESTING WAS CONDUCTED, WHICH DETERMINED THAT THE LIKELY CAUSE LOT MET ACCEPTANCE AND VALIDITY CRITERIA FOR ABBOTT CONTROLS AND THE PRODUCT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S REPORTED ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I B12 REAGENT LOT 53664UD00.
Description of Event or Problem
THE CUSTOMER REPORTED IMPRECISE ALINITY I B12 RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING DATA: UNIT OF MEASURE IS PG/ML ON (B)(6) 2023, SAMPLE ID (B)(6) GENERATED THE FOLLOWING 5 RESULTS 176, 304, 207, 225, & 199 WITH LOT 53664UD00. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Description of Event or Problem
THE CUSTOMER REPORTED IMPRECISE ALINITY I B12 RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING DATA: UNIT OF MEASURE IS PG/ML ON (B)(6) 2023, SAMPLE ID 9202 GENERATED THE FOLLOWING 5 RESULTS 176, 304, 207, 225, & 199 WITH LOT 53664UD00. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Additional Manufacturer Narrative
THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P67-32 AND THERE IS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P67-21 / 31. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.