BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3141338 · Received June 3, 2013

    Report

    Report Number
    2531779-2013-07472
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. ¿PUMP NOT PRIMED¿ AND ¿NO CARTRIDGE DETECTED¿ WARNINGS WERE OBSERVED IN THE BLACK BOX DATA. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO ISSUES. THE TIME AND DATE ON THE PUMP WAS SET CORRECTLY. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN THE AA BATTERY WAS RE-INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. THE PUMP WAS OPENED FOR INVESTIGATION. EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD MALFUNCTIONED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013 FOR BLOOD GLUCOSE (BG) ISSUES. THE REPORTER STATED THAT THE PATIENT¿S BG WAS 35 MG/DL, THE PATIENT WAS CONFUSED AND SEEMED TO BE IN A LOT OF PAIN. THE REPORTER STATED THAT DURING THE PATIENT¿S HOSPITALIZATION, HE WAS DISCONTINUED FROM INSULIN PUMP THERAPY AND TREATED WITH INTRAVENOUS (IV) INSULIN DRIP. THE PATIENT WAS REPORTEDLY BEING DISCHARGED THE DAY OF THE CALL TO ANIMAS. REVIEW OF THE PUMP BY ANIMAS CUSTOMER TECHNICAL SUPPORT (ACTS) REVEALED THE TIME AND THE DATE ON THE PATIENT¿S PUMP WAS INCORRECT; (B)(6) 2007, 16:30. THE REPORTER STATED HE DID RECALL THAT THE BATTERY IN THE PUMP WAS CHANGED A COUPLE OF DAYS PRIOR. ACTS NOTED SIGNIFICANT GAPS IN THE PATIENT¿S BASAL HISTORY AND MANY PRIMES FOR THE DATE RECORDED (B)(6) 2007. THE BASAL RATES WERE NOTED TO BE PROGRAMMED CORRECTLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED LOW BG WITH HOSPITALIZATION WHILE ON INSULIN PUMP THERAPY USING A PUMP THAT WAS SET WITH THE INCORRECT DATE AND TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244223 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R