BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1890288 · Received November 3, 2010

    Report

    Report Number
    2954323-2010-01516
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 5, 2010
    Report Date
    November 3, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS IDENTIFIED BY ADC CUSTOMER SERVICE THAT THE CUSTOMER WAS ATTEMPTING TO USE EXPIRED TEST STRIPS (LOT # 41344; EXPIRATION: JANUARY OF 2008). THIS CASE DOES NOT INVOLVE A PRODUCT MALFUNCTION AND NO FURTHER INVESTIGATION IS NECESSARY. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON (B)(6) 2010 AT 8:00 PM HE RECEIVED AN ERROR-6 DISPLAY MESSAGE ON HIS PRECISION XTRA BLOOD GLUCOSE METER AND AS A RESULT, HE LOST CONSCIOUSNESS. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED AND NO MEDICATIONS WERE REPORTEDLY TAKEN TO COUNTERACT THE EVENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 41344

    Patients

    Seq Age Sex Outcome Treatment
    1 Other