BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3202522 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09550
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/14/2013 WITH THE FOLLOWING FINDINGS: THE CURRENT TOTAL DAILY BASAL DELIVERIES WERE CORRECT AND BOLUS DELIVERIES WERE CORRECTLY REFLECTED IN THE DAILY INSULIN DELIVERY TOTALS. NO INSULIN DELIVERY INTERRUPTIONS OR PUMP MALFUNCTIONS WERE OBSERVED IN THE BLACK BOX DOWNLOAD. THE PUMP SETTINGS CONFIRMED THE IOB WAS SET TO 4 HOURS. THE PUMP SETTINGS CONFIRMED THE INSULIN TO CARBOHYDRATE RATIO WAS SET TO 1U:21G. THE INSULIN SENSITIVITY FACTOR WAS SET TO 140MG/DL. AFTER PERFORMING A BOLUS PERFORMED EZCARB BOLUS FOR 210 CARBS, THE PUMP CORRECTLY CALCULATED A 10 UNIT BOLUS AND DISPLAYED CORRECT IOB WHETHER BG WAS AT, BELOW OR ABOVE TARGET BG. INVESTIGATORS WERE UNABLE TO VERIFY OR DUPLICATE REPORTED ISSUE. THERE WAS NO DEFECT FOUND.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (INSULIN ON BOARD CALCULATION) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301425 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR