BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I B12 REAGENT KIT

    MDR report key: 13937858 · Received March 29, 2022

    Report

    Report Number
    3005094123-2022-00059
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Date of Event
    February 28, 2022
    Report Date
    July 13, 2022
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    CDD
    PMA / PMN Number
    K121314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699574 ALINITY I B12 REAGENT KIT RADIOASSAY, VITAMIN B12 CDD A.I.D.D LONGFORD 34522UD00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6) | ALNTY I PROCESSING MODU, 03R65-01, (B)(6)