BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 3545636 · Received December 31, 2013

    Report

    Report Number
    2954323-2013-00684
    Event Type
    Injury
    Date Received
    December 31, 2013
    Date of Event
    December 9, 2013
    Report Date
    December 9, 2013
    Product Code
    NBW
    PMA / PMN Number
    K040814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED METER SERIAL NUMBER (B)(4). THE RETURNED METER WAS INVESTIGATED UTILIZING CONTROL TEST STRIPS. METER POWERED ON WITH BUTTON DEPRESSION, TEST STRIP INSERTION, AND INSERTION OF CAL BAR. METER WAS OBSERVED TO POWER OFF WITH BUTTON DEPRESSION AND REMOVAL OF TEST STRIP. THREE CONTROL SOLUTION ASSAYS: 223, 231 AND 213 WERE PERFORMED AND THE METER WAS CONNECTED TO A PC WITH A SERIAL DATA CABLE. GLUCOSE LOG WAS DOWNLOADED AND COMPARED WITH METER GLUCOSE HISTORY. DID NOT OBSERVE INCORRECT DATA IN MEMORY. THE COMPLAINTS ARE NOT CONFIRMED.

    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. NOTE: THE ACTUAL DATE OF THE REPORTED MEDICAL EVENT IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIS ADC BLOOD GLUCOSE METER PRODUCED THE SAME UNSPECIFIED READING EVERY TIME HE ATTEMPTED TO TEST, AND STATED HIS METER WOULD NOT POWER OFF. CUSTOMER ADDITIONALLY REPORTED HE SELF-INJECTED GLUCAGON AS A RESULT OF THIS ISSUE. NO FURTHER INFORMATION WAS PROVIDED AS CUSTOMER DECLINED TO CONTINUE TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682058 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention