BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3972586 · Received August 1, 2014

    Report

    Report Number
    2531779-2014-22006
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/25/2014 WITH THE FOLLOWING FINDINGS: NO OCCLUSION ALARMS OBSERVED IN BLACK BOX OR ALARM HISTORY. AN EZPRIME SEQUENCE AND 24HR DURATION TEST COMPLETED WITH NO OCCLUSIONS OCCURRING. THE PUMP IS DETECTING CORRECT FORCE AT 5LBS. THE TOTAL DAILY DOSE ADDS UP CORRECTLY. THE PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. AN OCCLUSION WAS INDUCED AND PUMP GIVES APPROPRIATE AUDIBLE AND VISUAL "OCCLUSION DETECTED" ALARM ON HOME SCREEN. UNABLE TO DUPLICATE COMPLAINT. THE DISPLAY SCREEN HAS A PINKISH CONTRAST. AUDIO BOLUS BUTTON IS INTACT BUT IT IS NOT RESPONDING TO USER PRESSES. REMOVED BUTTON COVER; CONTAMINATION OBSERVED UNDER BUTTON COVER. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING THAT THERE WAS AN ABSENCE OF AN OCCLUSION ALARM. CUSTOMER SUPPORT (CS) REVIEWED THE ALARM HISTORY AND THERE WAS NO OCCLUSION ALARM IN THE HISTORY. THE SENSITIVITY WAS SET TO LOW. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 520MG/DL WITH ABDOMINAL PAIN/VOMITING, POLYDIPSIA, POLYURIA, NAUSEA AND SYMPTOMS OF DEHYDRATION. THE PATIENT DID NOT RECEIVE 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 ABSENCE OF OCCLUSION ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450215 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening