BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2012326 · Received March 9, 2011

    Report

    Report Number
    2954323-2011-02138
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    March 3, 2011
    Report Date
    April 15, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER ((B)(4)) AND TEST STRIPS (LOT # 45001A888) WERE RETURNED FOR AN INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED. CONTROL SOLUTION TESTS WERE PERFORMED AND RESULTS WERE WITHIN RANGE OF SPECIFICATION. THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE DATE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED SHE RECEIVED AN UNSPECIFIED HIGH READING ON HER PRECISION XTRA BLOOD GLUCOSE METER AND BASED ON THE READING SHE ADMINISTERED A "HIGH DOSE" OF INSULIN, AND SUBSEQUENTLY SHE HAD A HYPOGLYCEMIC EVENT WHEN SHE EXPERIENCED VERTIGO, TREMULOUSNESS, WEAKNESS AND SEIZURE. THE CUSTOMER ALSO REPORTED HER BLOOD GLUCOSE LEVEL FELL BELOW 40 MG/DL SEVERAL TIMES ON THE GLUCOSE METER. ALTHOUGH THE CUSTOMER REPORTED SHE WAS SEEN BY A DOCTOR AND DIAGNOSED WITH HYPOGLYCEMIA, NO MEDICAL TREATMENT WAS RENDERED. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED. THE CUSTOMER REPORTEDLY SELF-TREATED HER SYMPTOMS BY DRINKING TEA WITH SUGAR AND EATING CHOCOLATE. IN ADDITION, THE CUSTOMER REPORTED SHE COMPARED A READING OF 240 MG/DL SHE RECEIVED ON HER BLOOD GLUCOSE METER TO A READING OF 170 MG/DL OBTAINED ON A HEALTH CARE PROVIDER DEVICE, AND BOTH READINGS WERE OBTAINED WITHIN TEN MINUTES. 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 45001A888

    Patients

    Seq Age Sex Outcome Treatment
    1 Other