BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALERE NMP22 BLADDER CHEK 24T

    MDR report key: 12783652 · Received November 9, 2021

    Report

    Report Number
    1221359-2021-03461
    Event Type
    Injury
    Date Received
    November 9, 2021
    Report Date
    July 5, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    NAH
    UDI-DI
    10811877010569
    PMA / PMN Number
    P940035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER D1200 / LOT 158575 AND DEVICE PART NUMBER F4090 / LOT 154909. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS AND THERE WERE NO BROKEN OR UNSEALED DESICCANTS OBSERVED. THE CURRENT OVERALL INCIDENT RATE FOR BROKEN/DAMAGED/DEFECTIVE COMPONENTS FOR THIS SPECIFIC LOT BASED ON THE TOTAL DISTRIBUTED DEVICES IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Additional Manufacturer Narrative · 0

    CORRECTION: H10 THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER D1200 / LOT 158703 AND DEVICE PART NUMBER F4090 / LOT 154900. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS AND THERE WERE NO BROKEN OR UNSEALED DESICCANTS OBSERVED. THE CURRENT OVERALL INCIDENT RATE FOR BROKEN/DAMAGED/DEFECTIVE COMPONENTS FOR THIS SPECIFIC LOT BASED ON THE TOTAL DISTRIBUTED DEVICES IS 16.2%. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT THERE WERE AFFECTED KIT BOXES THAT HAD DAMAGED DESICCANT POUCHES. THE DESICCANT SCATTERED WHEN UNPACKING THE REAGENT BOARD AND THE PACKAGING BAG SPLASHED INTO THE EYES OF THE OPERATOR. THEY WENT TO THE OPHTHALMOLOGY DEPARTMENT FOR MEDICAL TREATMENT WITHOUT MAJOR PROBLEMS. NO OTHER SERIOUS INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677148 ALERE NMP22 BLADDER CHEK 24T BLADDERCHECK TEST & CONTROL KIT NAH ABBOTT DIAGNOSTICS SCABOROUGH 10811877010569

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other