BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 3852081 · Received June 5, 2014

    Report

    Report Number
    2954323-2014-00634
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 9, 2014
    Product Code
    NBW
    PMA / PMN Number
    K040814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE METER WAS RETURNED AND INVESTIGATED WITH RETURNED TEST STRIPS. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READING THE CUSTOMER REPORTED WAS FOUND IN THE METER MEMORY.

    Description of Event or Problem · 1

    A FIRE DEPARTMENT MEDICAL OFFICER REPORTED HIS ADC BLOOD GLUCOSE METER PROVIDED A HIGH READING OF 125 MG/DL COMPARED TO A HOSPITAL READING OF 47 MG/DL. THE MEDICAL OFFICER REPORTED THAT AT APPROXIMATELY 6:00 AM ON (B)(6), 2014, HE RECEIVED A CALL FROM A PATIENT BECAUSE OF STROKE LIKE SYMPTOMS (I.E. SLURRED SPEECH), AND UPON HIS ARRIVAL AT 6:10 AM, A BLOOD GLUCOSE RESULT OF 125 MG/DL WAS OBTAINED USING THE ADC METER. PATIENT WAS TRANSPORTED TO A LOCAL HOSPITAL AND AT APPROXIMATELY 6:25 AM, A HOSPITAL READING OF 47 MG/DL WAS OBTAINED. THE MEDICAL OFFICER COULD NOT CONFIRM WHAT, IF ANY, DIAGNOSIS OR TREATMENT THE PATIENT RECEIVED AT THE HOSPITAL BUT STATED, "THE PATIENT MIGHT RECEIVE GLUCOSE FROM THE HOSPITAL". THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329501 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 4500162818

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention