ALINITY I B12 REAGENT KIT
Received Mar 29, 2022 · Event occurred Feb 28, 2022
Report 3005094123-2022-00059 · MDR key 13937858
Device
Generic name
Radioassay, Vitamin B12
Manufacturer
A.i.d.d LongfordCatalog number
07P67-32
Lot number
34522UD00
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER QUESTIONED ALINITY I B12 RESULTS FOR 2 PATIENTS. THE CUSTOMER USES THE NORMAL RANGE > 200 PG/ML. THE FOLLOWING WAS PROVIDED BY THE CUSTOMER: PATIENT ID (B)(6) 2022 <83 PG/ML. (B)(6) 2022 129 PG/ML. (B)(6) 2022 88 PG/ML. (B)(6) 2022 184 PG/ML. THE CUSTOMER IS UNSURE WHICH RESULT FOR EACH TEST DATE IS CORRECT AND REPORTED THE MEAN BETWEEN THE TWO RESULTS. PATIENT ID (B)(6) 2022 191 PG/ML. (B)(6) 2022 263 PG/ML. (B)(6) 2022 218 PG/ML. (B)(6) 2022 186 PG/ML. THE CUSTOMER IS UNSURE WHICH RESULT FOR EACH TEST DATE IS CORRECT AND REPORTED THE MEAN BETWEEN THE TWO RESULTS. ON (B)(6) 2022, AN ADDITIONAL PATIENT WAS QUESTIONED BY THE CUSTOMER: ID (B)(6), INITIAL RESULT 198 PG/ML, REPEATED 551 PG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
MULTIPLE PATIENTS WERE REPORTED; REFER TO EVENT FOR A SUMMARY OF ALL SIDS AND ASSOCIATED TEST RESULTS. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Additional Manufacturer Narrative
THE COMPLAINT INVESTIGATION FOR IMPRECISE ALINITY I B12 RESULT 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 TESTING OF THE COMPLAINT LOT NUMBER. TRENDING REVIEW DETERMINED NO RELATED TREND FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED, AS RETURNS WERE NOT AVAILABLE. ACCURACY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 34522UD00, STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. DEVICE HISTORY RECORD REVIEW ON LOT NUMBER 34522UD00 DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT. 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 ALINITY I B12, LOT NUMBER 34522UD00, WAS IDENTIFIED.