BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3844343 · Received June 2, 2014

    Report

    Report Number
    2531779-2014-15516
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 07/11/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/02/2014 WITH THE FOLLOWING FINDINGS: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. A REVIEW OF THE PUMP BLACK BOX DATA REVEALED A CS 064-0008 CALL SERVICE ALARM. MOISTURE WAS VISIBLE BEHIND THE PUMP DISPLAY LENS DURING A VISUAL INSPECTION OF THE PUMP. A LEAK TEST WAS PERFORMED AND FAILED DUE TO A CRACK IN THE PUMP CASING NEAR THE DISPLAY. FURTHER TESTING COULD NOT BE COMPLETED DUE TO AN UNREADABLE DISPLAY CAUSED BY MOISTURE. THE PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE INGRESS WAS FOUND THROUGHOUT THE PUMP INTERIOR.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CALL SERVICE ALARM ISSUE) ISSUE. IT WAS REPORTED THAT THE USER BLOOD GLUCOSE (BG) READING WAS GREATER THAN 250 MG/DL; HOWEVER, THE BG READING DID NOT EXCEED 500 MG/DL. NO SYMPTOMS OF HYPERGLYCEMIA WERE REPORTED. THE ALLEGED BG EXCURSION DOES NOT MEET ANIMAS CRITERIA FOR A SERIOUS INJURY AND IS THEREFORE NOT REPORTABLE AS AN ADVERSE EVENT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT WITH THIS COMPLAINT. THERE WAS NO FURTHER INFORMATION AVAILABLE REGARDING THE COMPLAINT AT THIS TIME; IF FURTHER INFORMATION IS PROVIDED A FOLLOW UP REPORT SHALL BE MADE. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION OF A CALL SERVICE ALARM ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321475 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR