BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 12224205 · Received July 26, 2021

    Report

    Report Number
    3002809144-2021-00446
    Event Type
    Malfunction
    Date Received
    July 26, 2021
    Date of Event
    July 14, 2021
    Report Date
    August 10, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RETROSPECTIVE REVIEW, IT WAS DISCOVERED THAT THE INITIAL EMDR FOR THIS ISSUE WAS SUBMITTED UNDER THE CORRECT SUSPECT MEDICAL DEVICE BUT INCORRECT MANUFACTURER NAME, CITY AND STATE. MDR NUMBER 3016438761-2021-00291 HAS BEEN SUBMITTED FOR THE CORRECT MANUFACTURING SITE AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER. H3 OTHER TEXT : MDR NUMBER 3016438761-2021-00291 HAS BEEN SUBMITTED FOR THE CORRECT MANUFACTURING SITE AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED (B)(6) ELEVATED ALINITY I B12 RESULTS FOR ONE SAMPLE IN ADDITION TO QUALITY CONTROLS (QC) OUT OF RANGE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: 187 TO 883 NG/L): (B)(6) 2021: LEVEL 2 QC WAS OUT OF RANGE HIGH BUT REPEATED WITHIN RANGE. (B)(6) 2021: LEVEL 1 QC WAS OUT OF RANGE HIGH. PREVIOUS SAMPLES THAT WERE REPORTED OUT OF THE LABORATORY WERE RETESTED: SID (B)(6) INITIAL RESULT = (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122387 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT GMBH 03R6501 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 ALNTY I B12 RGT 1200T K, 07P67-32, 28132UD00.| ALNTY I B12 RGT 1200T K, 07P67-32, 28132UD00.