BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3953210 · Received July 23, 2014

    Report

    Report Number
    2531779-2014-21160
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    July 12, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/06/2014 WITH THE FOLLOWING FINDINGS: THE LAST BOLUS DELIVERY AND THE LAST BASAL DELIVERY WERE ON (B)(6) 2014. PUMP HISTORY SHOWS NO ALARMS OUTSIDE THE RANGE OF NORMAL PATIENT USE. THE BASAL AND BOLUSES ADD UP APPROPRIATELY TO TOTAL THE TOTAL DAILY DOSE; SHOWING THE PUMP WAS DELIVERING ACCURATELY UNTIL THE LAST DATE USED. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATION AND DELIVERING ACCURATELY. INVESTIGATORS WERE UNABLE TO DUPLICATE REPORTED COMPLAINT. THE DISPLAY SCREEN HAS 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 324MG/DL, EXTREMELY TIRED AND WEAK, EXTREME DROWSINESS/DIFFICULTY WAKING UP/CONFUSION, BUT NO KETONES. DURING TROUBLESHOOTING, CUSTOMER SUPPORT (CS) FOUND THAT THE BOLUS AND BASAL HISTORIES WERE AS EXPECTED AND DID NOT IDENTIFY ANY FOLLOWING POTENTIAL CAUSES OF PERCEIVED INACCURATE DELIVERY ISSUE. THE PATIENT DISCONTINUED PUMP USE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA AND THE PUMP CANNOT BE RULED OUT AS CAUSING/CONTRIBUTING TO THE HYPERGLYCEMIC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431199 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening