BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4130959 · Received September 30, 2014

    Report

    Report Number
    2531779-2014-27970
    Event Type
    Injury
    Date Received
    September 30, 2014
    Report Date
    September 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/20/2015 WITH THE FOLLOWING FINDINGS: BLACK BOX SHOWS UNACKNOWLEDGED ¿CS088¿ ALARMS FOR 4HR ON (B)(6) 2014, RETURNED BATTERY CAP AND TEST CARTRIDGE CAP WERE USED TO COMPLETE THE INVESTIGATION. TOTAL DAILY DOSE ADDS UP AND EQUALS THE PROGRAMMED BASAL RATE TARGET. NO ¿CS088¿ ALARM OR ANY EAW OCCURRED DURING THE INVESTIGATION, THE PRODUCT PERFORMS WITHIN SPECIFICATIONS. THE PUMP REFLECTED 24U AFTER A 24HR ON 1U/HR DURATION TEST, UNABLE TO DUPLICATE ¿CS088¿ COMPLAINT, THE PUMP¿S COVER WAS REMOVED, NO INTERMITTENT CONDITION WAS FOUND TO THE POWER PCB. 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 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING A CALL SERVICE 088 SERVICE ALARM ISSUE. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 29.5MMOL/L WITH POLYURIA, POLYDIPSIA AND NAUSEA. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE CARE OF DIABETES MANAGEMENT. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION THE PATIENT EXPERIENCED DUE TO AN ALLEGED CALL SERVICE ALARM ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609366 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Life Threatening