BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I B12

    MDR report key: 10280776 · Received July 15, 2020

    Report

    Report Number
    3005094123-2020-00148
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    May 28, 2020
    Report Date
    August 26, 2020
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD
    Product Code
    CDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D.11. ADDITIONAL INFORMATION THAT RESULTS WERE GENERATED ON MULTIPLE ALINITY I PROCESSING MODULES LIST 03R65-01 SERIALS (B)(6). THE CUSTOMER INDICATED THEY WERE USING LOT NUMBERS 11473UI00, 13116UI00 AND 05357UI00 DURING THE TIMEFRAME OF THIS EVENT. IT IS UNKNOWN WHICH LOT GENERATED EACH SPECIFIC DISCREPANT RESULT. LOT 11473UI00 EXPIRATION DATE 26OCT2020, DEVICE MANUFACTURE DATE 14JAN2020 LOT 13116UI00 EXPIRATION DATE 10DEC2020, DEVICE MANUFACTURE DATE 21FEB2020 LOT 05357UI00 EXPIRATION DATE 04MAY2020, DEVICE MANUFACTURE DATE 27JUL2019 THE TICKET SEARCH DETERMINED NORMAL COMPLAINT ACTIVITY FOR THE COMPLAINT LOTS. THE COMPLAINT TRENDING REPORT REVIEW DETERMINED THAT THERE IS NO ADVERSE TRENDS FOR THE ISSUE FOR THE PRODUCT. THE REVIEW OF HISTORICAL DATA SHOWED NO ISSUES CONCERNING IMPRECISE/ABERRANT RESULTS FOR THE COMPLAINT LOTS. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. LABELLING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT LIST 7P67, THAT HAS A SIMILAR US PRODUCT DISTRIBUTED IN THE US, LIST 7P67-21 / 31. THE CUSTOMER INDICATED THEY WERE USING LOT NUMBERS 11473UI00, 13116UI00 AND 05357UI00 DURING THE TIMEFRAME OF THIS EVENT. IT IS UNKNOWN WHICH LOT GENERATED EACH SPECIFIC DISCREPANT RESULT. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT OBSERVED ERRATIC (FALSE ELEVATED AND FALSE DEPRESSED) ALINITY I B12 RESULTS IN BOTH THE HIGH AND LOW RANGE WITH REPEAT MEASUREMENTS >30% FOR MULTIPLE SAMPLES. EXAMPLES PROVIDED: PATIENT C TESTED 222, 195, 220, 283 PMOL/L. PATIENT E TESTED 225, 160, 211, 224 PMOL/L. PATIENT ID (B)(6) TESTED 247, 182 PMOL/L, 36% DIFFERENCE ((B)(6) 2020). QUALITY CONTROL SHIFTS WERE ALSO OBSERVED. NO SPECIFIC INDIVIDUAL PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741930 ALINITY I B12 VITAMIN B12 CDD ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 AI01372, AI02738, (B)(6) | ALINITY I PROCESSING MODULE| ALINITY I PROCESSING MODULE| LIST 03R65-01, SERIAL (B)(6) | LIST 03R65-01, SERIALS (B)(6) ,