BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA

    MDR report key: 2061589 · Received April 18, 2011

    Report

    Report Number
    2954323-2011-02984
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 29, 2011
    Report Date
    June 8, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ADDITIONALLY: THE SERIAL NUMBER OF THE METER IN USE AT THE TIME OF THE MEDICAL EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    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. THE READING THE CUSTOMER REPORTED WAS NOT FOUND IN METER MEMORY.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE REPORTED METER WAS NOT RETURNED. AN APPROVED RETAINED METER WAS USED FOR PRODUCT INVESTIGATION THEREFORE THE REPORTED READINGS COULD NOT BE IDENTIFIED IN THE METER MEMORY LOG.

    Description of Event or Problem · 1

    CUSTOMER CALLED CUSTOMER SERVICE ON (B)(6) 2011 AND REPORTED THAT SOMETIME "AROUND (B)(6) 2010" SHE RECEIVED A READING OF 422 MG/DL ON HER PRECISION XTRA BLOOD GLUCOSE METER, WHICH WAS HIGHER THAN SHE FELT. CUSTOMER FURTHER REPORTED SUBSEQUENTLY EXPERIENCING "DISTRESS", EXTREME ANXIETY, LIGHTHEADEDNESS, TREMULOUSNESS AND A HEADACHE. CUSTOMER CALLED HER HEALTHCARE PROVIDER AND WAS DIRECTED TO GO TO A LOCAL HEALTHCARE FACILITY. AT THE EMERGENCY ROOM THEY RECEIVED A READING, ON AN UNKNOWN BRAND OF METER, OF "SLIGHTLY ABOVE 200 MG/DL". CUSTOMER DID NOT RECEIVE ANY DIAGNOSIS, BUT NOTED SHE WAS TREATED WITH AN INTRAVENOUS INFUSION OF UNKNOWN TYPE, "TO BRING DOWN GLUCOSE LEVEL". CUSTOMER ADDITIONALLY REPORTED SELF-TREATING PRIOR TO GOING TO THE E.R WITH HER USUAL DIABETES MEDICATIONS, GLUCOTROL AND GLUCOPHAGE. 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 45611

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention