BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1960715 · Received December 16, 2010

    Report

    Report Number
    2531779-2010-02934
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE PT'S MOM CONTACTED ANIMAS ON (B)(6) 2010 TO REPORT THAT THE PT WAS TREATED FOR HYPOGLYCEMIA AT THE HOSPITAL ON (B)(6) 2010. ON THE DAY OF THE HOSPITAL VISIT, THE PT REPORTEDLY HAD BOLUSED WITH THE PUMP AT 7:30PM FOR A PRETZEL (5.7 UNITS, NO BLOOD GLUCOSE TEST) AND 8PM FOR DINNER (7.3 UNITS, 136 MG/DL BLOOD GLUCOSE TEST). AT 9PM THE SAME DAY, THE PT'S BLOOD GLUCOSE DROPPED TO 35 MG/DL. THE PT RECEIVED TREATMENT FOR HYPOGLYCEMIA AT THE HOSPITAL AND WAS SENT HOME THE SAME DAY. THE PT'S MOM DID NOT HAVE THE PUMP AT THE TIME OF THE CALL TO TROUBLESHOOT THE PUMP. THE PT'S MOM STATED SHE BELIEVES THAT THE PT MAY HAVE MISCALCULATED THE CARBOHYDRATES. AFTER 2 FAILED ATTEMPTS TO REACH THE PT'S MOM FOR FOLLOW-UP, THE ANIMAS REPRESENTATIVE WAS ABLE TO REACH THE PT'S MOM ON (B)(6) 2010 TO TROUBLESHOOT THE PUMP. THE ANIMAS REPRESENTATIVE DISCOVERED THAT THE PUMP'S DATE SETTING WAS INCORRECT BUT THE TIME WAS CORRECT: THE PUMP'S DATE SETTING WAS (B)(6) 2010 AT THE TIME OF THE FOLLOW-UP CALL. THE INCORRECT DATE SETTING DOES NOT IMPACT THE BASAL SETTINGS THAT HAVE BEEN PROGRAMMED INTO THE PUMP SETTINGS. THE PT'S MOM CONFIRMED THAT THE BASAL SETTINGS WERE CORRECT AND THERE WERE NO ALARMS ON (B)(6) 2010. THERE WAS NO INDICATION THAT THE PUMP MALFUNCTIONED; HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT REPORTEDLY RECEIVED TREATMENT AT THE HOSPITAL FOR HYPOGLYCEMIA AFTER TAKING BOLUSING WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| L| R