BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1850625 · Received October 1, 2010

    Report

    Report Number
    2954323-2010-01358
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    August 22, 2010
    Report Date
    November 8, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: CUSTOMER'S FRIEND REPORTED CUSTOMER ATTEMPTED TO USE EXPIRED TEST STRIP (EXPIRED ON AUGUST, 2007).

    Additional Manufacturer Narrative · 1

    AS CUSTOMER'S METER WAS NOT RETURNED AND THE REPORTED STRIP LOT (40799) WAS EXPIRED, A DEVICE HISTORY REVIEW OF THE METER WAS REQUESTED AND PERFORMED. THE DEVICE HISTORY REVIEW FOR METER SN (B)(4) INDICATED THE DEVICE WAS PERFORMING WITHIN ITS PERFORMANCE CLAIMS AND MET THE MANUFACTURER'S QUALITY SPECIFICATIONS PRIOR TO ITS RELEASE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER'S FRIEND REPORTED CUSTOMER RECEIVED A READING OF 125 MG/DL FROM HIS PRECISION XTRA METER. CUSTOMER'S FRIEND ALSO REPORTED CUSTOMER EXPERIENCED SYMPTOMS OF WEAKNESS AND INCOHERENCE. CUSTOMER'S FRIEND FURTHER REPORTED CUSTOMER WENT TO A HEALTH CARE FACILITY WHERE THEY OBTAINED A READING OF 319 MG/DL FROM THEIR HCP METER AND TREATED CUSTOMER WITH UNSPECIFIED TREATMENT. THE DIAGNOSIS AT THE HEALTH CARE FACILITY IS UNKNOWN. ADC CUSTOMER SERVICES MADE MULTIPLE ATTEMPTS TO CONTACT CUSTOMER FOR ADDITIONAL INFORMATION BUT WITHOUT ANY SUCCESS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 51 MG/DL AND 142 MG/DL WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 40799

    Patients

    Seq Age Sex Outcome Treatment
    1 Other