BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2221061 · Received August 23, 2011

    Report

    Report Number
    2954323-2011-04284
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    August 2, 2011
    Report Date
    September 22, 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 AVAILABLE. NOTE: THE DATE OF MANUFACTURE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Description of Event or Problem · 1

    A CUSTOMER'S MOTHER REPORTED A LOW READING ON HER DAUGHTER'S PRECISION XTRA GLUCOSE METER WHEN COMPARED TO A HEALTH CARE PROFESSIONAL'S METER. THE CUSTOMER'S MOTHER REPORTED THAT HER (B)(6) DAUGHTER HAD BEEN EXPERIENCING STOMACH PAINS AND WEIGHT LOSS, AND SHE TOOK HER DAUGHTER TO THE DOCTOR'S OFFICE ON (B)(6) 2011. THE MOTHER REPORTED A READING OF 55 MG/DL WAS OBTAINED ON HER DAUGHTER'S PRECISION XTRA METER COMPARED TO A READING OF 496 MG/DL TAKEN ON THE DOCTOR'S GLUCOSE METER. THE CUSTOMER'S MOTHER REPORTED HER DAUGHTER WAS DIAGNOSED WITH HYPERGLYCEMIA AND KETOACIDOSIS. TREATMENT WAS DESCRIBED AS "A NEW METER AND CHECKING FOR FAULTY PUMPS" (HER DAUGHTER WAS USING AN UNSPECIFIED INSULIN PUMP). NO SELF-TREATMENT WAS REPORTED. THERE IS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001F132

    Patients

    Seq Age Sex Outcome Treatment
    1 Other