BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3923594 · Received July 9, 2014

    Report

    Report Number
    2531779-2014-19463
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 02/17/2017. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/27/2017 WITH THE FOLLOWING FINDINGS: THE BLACK BOX BEGAN ON (B)(6) 2016. DUE TO CONTINUOUS USE OF THE PUMP, THE BLACK BOX DATA/HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN. THE AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USERS PROGRAMMED BASAL RATES. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. THE ORIGINAL COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED ABOVE THE BUMPER PAD AND THE DISPLAY SCREEN HAD A PINKISH CONTRAST. 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 REQUEST FOR RETURN 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, ALLEGING A HYPOGLYCEMIC EVENT DUE TO AN INACCURATE DELIVERY ISSUE. IT WAS REPORTED THAT INACCURATE DELIVERY STARTED ON (B)(6) 2014, AND ON AN UNSPECIFIED DATE, THE PATIENT HAD BLOOD GLUCOSE (BG) READING OF 30 MG/DL WITH DIZZINESS AND UNSTEADINESS WHEN STANDING AND/OR WALKING. NO TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT WAS REPORTED AND REPORTEDLY THE PATIENT HAD REMAINED ON PUMP THERAPY AFTER RECENT BASAL RATE ADJUSTMENT BY HEALTH CARE PROVIDER. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE POTENTIAL CAUSES FOR INACCURATE DELIVERY AND DETERMINED THAT ALL BASAL AND BOLUS DELIVERIES WERE CORRECT AND AS PROGRAMMED. FURTHER REVIEW SHOWED THAT THE PATIENT¿S INSULIN REGIMEN WAS NOT ADJUSTED FOR CHANGES IN STRESS/PAIN LEVEL AND THE MISCOUNTING CARBOHYDRATE INTAKES WERE MISCOUNTED. IN ADDITION, THE REPORTER ACKNOWLEDGED THAT WHEN PROGRAMING FOR BOLUS, THE WEIGHT OF CARBOHYDRATE INTAKE WAS MISTAKENLY ENTERED AS UNITS OF INSULIN, RESULTING IN DELIVERY OF UNINTENDED EXCESS INSULIN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCE SERIOUS HYPOGLYCEMIA WHILE ON PUMP THERAPY. THE BG EXCURSION IS ATTRIBUTABLE TO A USE ERROR IN THAT THE BOLUS WAS INCORRECTLY PROGRAMMED. ADDITIONAL DIABETES MANAGEMENT FACTORS MAY HAVE ALSO CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399660 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening