BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3863766 · Received June 10, 2014

    Report

    Report Number
    2531779-2014-16355
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 31, 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 07/11/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/03/2014 WITH THE FOLLOWING FINDINGS:. UNABLE TO VERIFY A TIME/DATE RESET TO THE DEFAULT SETTING IN THE BLACK BOX. A MANUAL TIME CHANGE WAS OBSERVED ON 06/01/2014 FROM 10:40 TO 22:40. PUMP WAS EXERCISED FOR 24HRS TO ENSURE THE INTERNAL BATTERY WAS FULLY CHARGED. AFTER 24HRS THE BATTERY WAS REMOVED FOR 6HRS. THE BENCH TOP ANALYSIS CONFIRMED WHEN THE BATTERY WAS REINSERTED AFTER 6HRS WITHOUT POWER THE TIME AND DATE RESET TO FACTORY DEFAULT. PUMP SUCCESSFULLY PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. REMOVAL OF THE PUMP COVER AND A VISIBLE INSPECTION CONFIRMED THE INTERNAL BATTERY WAS LEAKING. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT IS CRACKED AT THE CASE SEAL. RETURNED BATTERY CAP ABLE TO FULLY ATTACH TO THE PUMP AND WAS USED TO COMPLETE ALL TESTING. 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 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE WHEN THE BATTERY IS REMOVED FROM THE PUMP FOR LESS THAN 24 HOURS, THE TME/DATE REVERTS TO THE DEFAULT SETTINGS. THE TIME/DATED ISSUE IS NOT BEING REPORTED BECAUSE THE PUMP DISPLAYS THE VERIFY SCREEN AFTER A BATTERY CHANGE AND THE TIME AND DATE MUST BE SET TO CONFIRM THE VERIFY SCREEN. THE PATIENT HAS A BLOOD GLUCOSE >500 MG/DL, WITH NO SYMPTOMS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341123 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening