BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4921130 · Received July 17, 2015

    Report

    Report Number
    2531779-2015-24174
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Report Date
    June 30, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1; DATE OF SUBMISSION: 09/02/2015 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 08/11/2015 WITH THE FOLLOWING FINDINGS: THE REPORTED CS-064 'CALL SERVICE ALARM' ISSUE COULD NOT BE ADEQUATELY INVESTIGATED DUE TO A DISTORTED/ILLEGIBLE DISPLAY; NO CONCLUSIONS COULD BE DETERMINED IN REGARDS TO THE REPORTED ISSUE. SEVERAL CS-064 'CALL SERVICE ALARMS', WHICH CAN BE INDICATIVE OF THE TYPE OF ISSUE THAT WAS REPORTED, WERE OBSERVED IN THE BLACK BOX DATA. EVIDENCE OF MOISTURE INGRESS WAS OBSERVED BEHIND THE DISPLAY LENS. THE PUMP POWERED ON, AS CONFIRMED BY THE PRESENCE OF THE AUDITORY AND VIBRATORY CUES; HOWEVER, THE DISPLAY SCREEN WAS OBSERVED TO BE DISTORTED/ILLEGIBLE DUE TO INTERNAL MOISTURE DAMAGE. THE PUMP CASE WAS REMOVED, AND FURTHER EVIDENCE OF MOISTURE INGRESS WAS FOUND ON INTERNAL COMPONENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 064) ISSUE. IT WAS REPORTED THAT A CS-064 ¿CALL SERVICE ALARM¿ OCCURRED DURING THE REWIND/LOAD STEP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466677 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR