BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4221306 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31272
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/20/2015 WITH THE FOLLOWING FINDINGS: 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. ON INVESTIGATION, THE ALLEGED LOSS OF PRIME ISSUE WAS NOT DUPLICATED. REVIEW OF BLACK BOX DATA FOUND THAT THE AVAILABLE DATE RANGE DID NOT COVER THE COMPLAINT DATE DUE TO CONTINUED CUSTOMER USE. REVIEW OF THE AVAILABLE DATE RANGE SHOWED THAT THE TOTAL DAILY DELIVERY CORRECTLY REFLECTED THE USER¿S PROGRAMMED BASAL RATES. USING THE RETURNED BATTERY CAP, THE PUMP POWERED UP AND FUNCTIONED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR BASAL EXERCISE WERE EXECUTED WITHOUT INCIDENCES. THE PUMP DELIVERY ACCURACY WAS WITHIN SPECIFICATIONS. AUDIO AND NORMAL BOLUS EXERCISES WERE DELIVERED AND RECORDED CORRECTLY.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED 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 THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE ON PUMP THERAPY. REPORTEDLY, ON AN UNSPECIFIED DATE, THE PATIENT¿S BLOOD GLUCOSE (BG) READING WAS BETWEEN 300 AND 400 MG/DL WITH BLURRED VISION AND EXTREME DROWSINESS/DIFFICULTY WAKING UP/CONFUSION. IT WAS REPORTED THAT THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. THE PATIENT ALLEGEDLY REMAINED ON PUMP THERAPY WITHOUT ANY RECENT ADJUSTMENTS TO THE PUMP SETTINGS. CUSTOMER TECHNICAL SUPPORT AGENT REVIEWED THE EVENT WITH THE REPORTER. IT WAS REPORTED THAT THE INACCURATE DELIVERY ISSUE STARTED ABOUT TWO MONTHS AGO. REVIEW OF POTENTIAL CAUSES FOR INACCURATE DELIVERY DETERMINED THAT ALL BASAL AND BOLUS DELIVERIES WERE CORRECT AND AS PROGRAMMED. REVIEW OF POTENTIAL CAUSES FOR BG ISSUES REVEALED THAT THE RECOMMENDED DOSAGE BY BOLUS CALCULATOR WAS OVER REDDENED, MANUAL CALCULATION OF DOSAGE WAS INCORRECT, BOLUS SETTINGS WERE INCORRECTLY PROGRAMMED, AND THERE WERE UNSPECIFIED NUTRITIONAL CHANGES. TROUBLESHOOTING DID NOT IDENTIFY ANY SPECIFIC PUMP MALFUNCTIONS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A SEVERE HYPERGLYCEMIC EVENT DUE TO A USE ERROR IN THAT SOME OF THE BOLUS FEATURES WERE NOT EXECUTED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701111 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Life Threatening