BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4240773 · Received November 10, 2014

    Report

    Report Number
    2531779-2014-32012
    Event Type
    Injury
    Date Received
    November 10, 2014
    Report Date
    October 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 06/02/2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/18/2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX STARTED ON 04/09/2015. THE BLACK BOX DATA/HISTORIES FOR THE EVENT HAD BEEN OVERWRITTEN DUE TO CONTINUED USE OF THE PUMP. NO TIME/DATE ISSUE OBSERVED IN CURRENT BLACK BOX DATA. A TIMEKEEPING ACCURACY TEST WAS PERFORMED AND THE PUMP MAINTAINED TIME ACCURATELY DURING THE 5 DAY DURATION TEST; HOWEVER, WHEN THE PUMP WAS LEFT WITHOUT POWER FOR 1HR AND THE PUMP WAS POWERED BACK ON IT HAD RETURNED TO THE DEFAULT TIME/DATE 12:00AM 1/1/2007. THE AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USERS PROGRAMMED BASAL RATES. THE PUMP PASSED A DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. THE PUMP WAS OPENED AND THE INTERNAL BATTERY (BT1) WAS FOUND TO BE LEAKING. THE TIME TEST WAS STARTED BUT NOT COMPLETED DUE TO THE INTERNAL BATTERY FAILURE. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED TO BE RETURNED TO ANIMAS. 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED BLOOD GLUCOSE (BG) VALUES RANGING FROM 35MG/DL WITH CONFUSION TO GREATER THAN 250 MG/DL, BUT LESS THAN 500 MG/DL WITHOUT SYMPTOMS. REPORTEDLY, THE PATIENT REMAINED ON THE PUMP AND DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REPORTED THAT THE PATIENT MUST HAVE CHANGED THE TIME WHEN THEY CHANGED THE BATTERY; THE TIME WAS EXACTLY 12 HOURS OFF. ALSO DURING TROUBLESHOOTING, THE PUMP WAS ABLE TO MAINTAIN THE CORRECT TIME/DATE WHEN THE BATTERY WAS REMOVED FOR LESS THAN 24 HOURS AND WHEN THE PUMP WAS REBOOTED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED BG EXCURSIONS DUE TO USE ERROR IN INCORRECTLY SETTING THE TIME IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723702 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening