BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 3930371 · Received July 11, 2014

    Report

    Report Number
    2954323-2014-00760
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Product Code
    NBW
    PMA / PMN Number
    K040814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE TEST STRIP LOT NUMBER IS UNKNOWN, HENCE THE DATE OF MANUFACTURE IS ALSO UNKNOWN. THE DATE LISTED IN SECTION H-4 IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE METER WAS RETURNED AND INVESTIGATED WITH CONTROL 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2014, "AROUND 8:30 AM" HE RECEIVED READINGS FROM HIS ADC BLOOD GLUCOSE METER OF 8.2 MMOL/L (148 MG/DL) AND 8.6 MMOL/L (155 MGD/L). CUSTOMER FURTHER REPORTED HE WAS FEELING "BAD", HAD LAIN DOWN AND SUBSEQUENTLY BECAME UNCONSCIOUS. CUSTOMER'S WIFE TREATED HIM WITH HYPOSTOP AND THEN CALLED THE PARAMEDICS BECAUSE HE HAD STILL NOT REGAINED CONSCIOUSNESS. UPON ARRIVAL THEY RECEIVED A READING WITH THEIR METER OF 1.2MMOL/L (22 MG/DL) AND TREATED CUSTOMER WITH UNSPECIFIED "INJECTIONS". THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406758 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R