BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2882466 · Received December 20, 2012

    Report

    Report Number
    2531779-2012-14947
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 11, 2012
    Report Date
    December 12, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/24/2017 WITH THE FOLLOWING FINDINGS: THE BLACK BOX BEGINS ON 2017-02-01. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA/HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN. AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. THE PUMP PASSED DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. MANUALLY CALCULATED AN EZCARB AND EZBG BOLUS; RETURNED PUMP CORRECTLY CALCULATED THE SAME UNITS. PUMP¿S BOLUS CALCULATION FEATURE FOUND TO BE FUNCTIONING PROPERLY. UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. 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.

    Description of Event or Problem · 1

    THE PATIENT'S HEALTH CARE PROVIDER (HCP) CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THE PATIENT WAS HOSPITALIZED AND HAD AN ELEVATED BLOOD GLUCOSE OF 44 MMOL/L WITH NAUSEA, VOMITING, DIARRHEA, AND DEHYDRATION. THE HCP INDICATED THAT THE PATIENT APPEARED TO HAVE A VIRUS. THE PATIENT WAS REPORTEDLY TREATED WITH INTRAVENOUS INSULIN AND FLUIDS. THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 REPORTING BLOOD GLUCOSE LEVELS WERE ELEVATED INTO THE 20'S MMOL/L FROM (B)(6) 2012; THE PATIENT REPORTED HAVING VOMITING, AND DIARRHEA ON THESE DAYS AND THE PATIENT WAS TAKING MEDICATION FOR THESE SYMPTOMS. THE PATIENT INDICATED THAT THE SUPPLIES WERE PLACED ON (B)(6) 2012 AND WERE USED UNTIL (B)(6) 2012 WHICH IS LONGER THAN INDICATED. THE PUMP HISTORY WAS REVIEWED AND CONFIRMED THAT THERE WERE NO RELATED ALARMS, THE PUMP WAS NOT SUSPENDED AND ALL BOLUSES IN THE PUMP HISTORY WERE DELIVERED AND ACCOUNTED FOR. THE PATIENT STATED THAT ON (B)(6) 2012 THE PUMP CALCULATED A BOLUS THAT WAS LESS THAN WHAT WAS REALLY NEEDED TO COVER THE ELEVATED BLOOD GLUCOSE LEVELS. THE PATIENT REPORTED THAT A FAMILY MEMBER MANUALLY CALCULATED THE BOLUS AMOUNT THAT WAS GIVEN AND THE BLOOD GLUCOSE LEVEL DECREASED TO 5.7 MMOL/L. THE PATIENT INDICATED THAT THE PUMP DID NOT CALCULATE THE CORRECT AMOUNT FOR THE BOLUS AND WAS QUESTIONING IF IT WAS PROGRAMMED WITH HER PROPER SETTINGS. THE PATIENT REPORTED BEING UNSURE OF SOME OF THE PUMP SETTINGS AND STATED THAT A FOLLOW UP WITH THE HCP WOULD CONFIRM THE SETTINGS. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR HYPERGLYCEMIA WHILE USING THE INSULIN PUMP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L