BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2902395 · Received January 8, 2013

    Report

    Report Number
    2954323-2013-00007
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 14, 2012
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. WHILE TROUBLESHOOTING WITH CUSTOMER SERVICE IT WAS REVEALED THE METER WAS NOT PROPERLY CALIBRATED AND THE DATE AND TIME MAY NOT HAVE BEEN SET CORRECTLY. THE DATE OF MANUFACTURE IS UNKNOWN. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE REPORTED PRODUCT WAS RETURNED AND VISUAL INSPECTION OF THE LOG WAS PERFORMED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. REVIEW OF THE INTERNAL MEMORY LOG INDICATED ERROR ISSUES WERE RELATED TO A NONCOMPATIBLE CALIBRATION BAR AND A DEFECTIVE CALIBRATION BAR. NO ELECTRIC STATIC DISCHARGE (ESD) WAS OBSERVED. IT WAS ALSO OBSERVED THAT THE CUSTOMER NEVER SET THE DATE AND TIME OF THEIR METER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT APPROXIMATELY ONE MONTH PRIOR TO HIS MEDICAL EVENT ON (B)(6), 2012, HE NOTICED AN E-6 MESSAGE ON THE DISPLAY OF HIS ADC BLOOD GLUCOSE METER. HE FURTHER REPORTED THAT ON (B)(6) 2012 WHILE SHOPPING HE FELT "UNSTEADY, A LITTLE DIZZINESS AND WAS A LITTLE WEAK", RESULTING IN A LOSS OF CONSCIOUSNESS. PARAMEDICS WERE CALLED AND UPON THEIR ARRIVAL OBTAINED A READING OF 40 MG/DL ON THEIR UNKNOWN BRAND OF METER. CUSTOMER WAS TRANSPORTED TO A LOCAL HEALTHCARE FACILITY WHERE HE WAS DIAGNOSED WITH HYPOGLYCEMIA. CUSTOMER WAS UNABLE TO REPORT WHAT TREATMENT MAY HAVE BEEN ADMINISTERED BECAUSE HE WAS UNCONSCIOUS AT THE TIME, BUT NOTED HIS HEALTHCARE PROVIDER WAS "UNABLE TO ANALYZE (HIS) BLOOD BECAUSE (HIS) VEINS COLLAPSED". CUSTOMER REPORTEDLY SELF-TREATED WITH JUICE. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9723 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001J264

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| O| R