BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRUEBALANCE

    MDR report key: 2792453 · Received October 10, 2012

    Report

    Report Number
    1052693-2012-00030
    Event Type
    Other
    Date Received
    October 10, 2012
    Date of Event
    September 11, 2012
    Report Date
    October 10, 2012
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON PATIENT MEDICAL INTERVENTION, AFTER ADMINISTRATION OF INSULIN, BASED ON A GLUCOSE RESULT, COMPLAINT IS REPORTABLE. RETURNED PRODUCT INVESTIGATION IS IN PROCESS. CONTROL SOLUTION TEST PERFORMED BY USER WAS IN RANGE. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS TEST STRIP LOT. (B)(4).

    Description of Event or Problem · 1

    MOTHER OF PATIENT STATES THAT HIS BLOOD GLUCOSE RESULT WAS 527. THE MOTHER ADMINISTERED INSULIN. AFTER TWO HOURS, HER SON WAS NOT RESPONDING. EMS WAS CALLED AND TOOK HER SON TO THE HOSPITAL. NO OTHER INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OR PATIENT'S CONDITION. THE CUSTOMER CARE REPRESENTATIVE HAD THE MOTHER PERFORM A CONTROL TEST AND CONTROL RESULT WAS IN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUEBALANCE BM3778

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization