BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRUE2 GO

    MDR report key: 3338726 · Received September 4, 2013

    Report

    Report Number
    1052693-2013-00193
    Event Type
    Other
    Date Received
    September 4, 2013
    Date of Event
    August 28, 2013
    Report Date
    September 2, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080710
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. CUSTOMER COMPLAINT TO DISTRIBUTOR ((B)(4)) AND DISTRIBUTION REPORTED COMPLAINT TO NDI. CUSTOMER FELT THAT THE METER WAS RUNNING HIGH AND RETURNED IT TO THE PHARMACY WHERE PURCHASED ((B)(6)). PHARMACIST PERFORMED A TEST ON THE METER AND CUSTOMER REPORTED THAT THE READING WAS "OFF". PHARMACY EXCHANGED METER WITH ANOTHER. CUSTOMER REPORTED THAT THE NEW METER WAS ALSO RUNNING HIGH. CUSTOMER STATES THAT SHE ENDED UP IN THE HOSPITAL BECAUSE THE METER WAS REPORTING HER BLOOD SUGAR WAS ONE THING, AND IT WAS LOW. CUSTOMER CARE AT NDI ATTEMPTED TO CONTACT CUSTOMER FOR MORE INFO AND RECEIVED THE MESSAGE THAT "CANNOT ACCEPT CALLS AT THIS TIME". A COMPLAINT FROM THE CUSTOMER WAS REPORTED ON (B)(6), WHERE CUSTOMER STATED METER WAS READING HIGH. CONTROL TEST PERFORMED (44) WAS WITHIN RANGE (31-61). TROUBLESHOOTING THE MEMORY DURING THE CALL DID NOT SHOW ANY HIGH RESULTS IN MEMORY AND BACK TO BACK BLOOD TESTS PERFORMED AT THE TIME OF THE CALL YIELDED RESULTS OF 90MG/DL AND 83MG/DL. CUSTOMER STATED THAT AN EARLIER RESULT WAS 89MG/DL AND SHE FELT THAT IT SHOULD HAVE BEEN MUCH LOWER DUE TO THE WAY SHE WAS FEELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439713 TRUE2 GO BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUE2GO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization