BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2920110 · Received January 17, 2013

    Report

    Report Number
    2531779-2013-00797
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 27, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/20/2017 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED CORRUPTED DATA DUE TO A DEFECTIVE EEPROM COMPONENT. THE PUMP INFORMATION FOR THE COMPLAINT DATE WAS NOT AVAILABLE. THE PUMP WAS RUN FOR 24 HOURS AND EMITTED A CALL SERVICE 006 ALARM. THE TESTING WAS UNABLE TO BE COMPLETED DUE TO THE CALL SERVICE ALARM. 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)2012 THE PATIENT CONTACTED ANIMAS ALLEGING THAT IN (B)(6)HE HAD EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) ON TWO OCCASIONS OF 504MG/DL AND 507MG/DL. THE PATIENT DENIED KETONES OR SYMPTOMS. THE PATIENT COULD NOT PROVIDE SPECIFIC DATES FOR THE REPORTED BG EXCURSIONS. THE PATIENT STATED THAT HE ATTEMPTED TO CORRECT VIA THE PUMP DURING BG ELEVATIONS, WITHOUT SUCCESS, AND FINALLY DISCONTINUED INSULIN PUMP THERAPY (IPT) ON (B)(6) 2012. THE PATIENT STATED THAT HE HAS BEEN ON A BACK-UP PLAN FOR INSULIN DELIVERY, AND CALLED ANIMAS TO REVIEW THE PUMP PRIOR TO RESUMING IPT SINCE HIS HEALTHCARE PROVIDER (HCP) WANTS HIM TO RESUME IPT. THE PATIENT STATED THAT HE HAS HAD INCREASED INSULIN NEEDS SINCE CEASING IPT ON (B)(6) 2012, AND NOTED THAT HIS HCP WILL BE CHANGING HIS BASAL SETTINGS PRIOR TO RESUMING IPT. A REVIEW OF THE PUMP HISTORIES NOTED SOME OCCLUSION ALARMS, BUT CUSTOMER TECHNICAL SUPPORT (CTS) DETERMINED THAT THESE ALARMS WOULD NOT HAVE RESULTED IN THE REPORTED BG ISSUES. ALL SETTINGS AND HISTORIES WERE FOUND TO BE CORRECT DURING TROUBLESHOOTING. THERE WAS NO PUMP DEFECT FOUND. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA OF UNKNOWN CAUSE WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26218 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening