BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3964870 · Received July 29, 2014

    Report

    Report Number
    2531779-2014-21730
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    July 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    FOLLOW-UP #1: DATE OF SUBMISSION 3/28/2016 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/09/2016 WITH THE FOLLOWING FINDINGS: BLACK BOX CONTAINS DATES FROM (B)(6) 2016. BLACK BOX AND HISTORIES FOR ALARM REPORTED (B)(6) 2014 OVERWRITTEN. AVAILABLE DAILY INSULIN DELIVERY TOTALS REFLECT PROGRAMMED BASAL RATES. NO ALARMS RELATED TO PI OBSERVED IN ALARM HISTORY. PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. EXERCISED PUMP FOR 24 HOURS, AFTER 24 HOURS NO CALL SERVICE ALARMS WERE RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 533 MG/DL AND THAT THERE HAD BEEN A CALL SERVICE ALARM ISSUE CUSTOMER SUPPORT THROUGH TROUBLESHOOTING, FOUND NO PRODUCT ISSUE AND DEEMED THE ALARM ISSUE TO BE TRAINING MISUSE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442287 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening