BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2072260 · Received April 28, 2011

    Report

    Report Number
    2954323-2011-03090
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 28, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE CUSTOMER WAS USING EXPIRED TEST STRIPS ((B)(6) 2010). THERE IS NO INDICATION OF PRODUCT MALFUNCTION. NO INVESTIGATION OF THE PRODUCT IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER'S HEALTH AIDE REPORTED THE CUSTOMER RECEIVED AN E-6 MESSAGE ON THE DISPLAY OF HIS PRECISION XTRA BLOOD GLUCOSE METER. SHE FURTHER REPORTED HE HAD BEEN USING EXPIRED TEST STRIPS FOR THREE WEEKS WITHOUT REALIZING THEY WERE EXPIRED. SHE FURTHER REPORTED THAT ON (B)(6) 2011 HE EXPERIENCED A SEIZURE. PARAMEDICS WERE CALLED AND TRANSPORTED CUSTOMER TO A LOCAL HEALTHCARE FACILITY WHERE HE WAS DIAGNOSED WITH A "SEIZURE". CUSTOMER WAS GIVEN "ANTI-SEIZURE" MEDICATION, A MAGNESIUM SUPPLEMENT AND AN UNSPECIFIED "ANTIBIOTIC" FOR "PNEUMONIA, BECAUSE HE INHALED WITH THE SEIZURE". SHE FURTHER REPORTED HE SELF-TREATED WITH BACLOFEN 10 MG, NOVOLIN INSULIN 100 UNITS, "INSULIN R", "OXALATE 20 MG", HYDROCODONE 7.5 MG/TYLENOL 500 MG, DARVOCET (PROPOXYPHENE) N-100, PROPANOLOL 20 MG, PREVACID (LANSOPRAZOLE) 30 MG AND TRAZODONE 50 MG. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 44134

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R