BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3230311 · Received July 16, 2013

    Report

    Report Number
    2531779-2013-11031
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BATTERY CAP AND PUMP HAVE NOT BEEN RETURNED TO ANIMAS. 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. 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 11/24/2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A REVIEW OF THE PUMP BLACK BOX DATA REVEALED THAT INFORMATION FROM THE EVENT DATE HAD BEEN OVERWRITTEN DUE TO CONTINUED USE OF THE PUMP. THE AVAILABLE BLACK BOX SHOWED NO EVIDENCE OF AN INTERMITTENT POWER ISSUE. A VISUAL INSPECTION OF THE PUMP SHOWED THAT THE BATTERY COMPARTMENT WAS INTACT. THE RETURNED BATTERY CAP CONTACT DIMENSIONS WERE WITHIN SPECIFICATIONS AND THE CAP WAS UNDAMAGED. THE PUMP POWERED ON WITH THE CAP AND WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES. THE PUMP COVER WAS OPENED AND NO INTERNAL DEFECT WAS FOUND. THE COMPLAINT WAS NOT DUPLICATED DURING TESTING. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS DIM AND DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE PUMP REBOOTED WITHOUT USER INTERVENTION MORE THAN ONE TIME. CUSTOMER SUPPORT CONCLUDED THAT THE BATTERY CAP MAY HAVE BEEN THE CAUSE OF THE INTERMITTENT POWER ISSUE. THE REPORTER ALLEGED THAT THE PATIENT¿S BG REACHED 400 MG/DL WITH NO SYMPTOMS, WHICH DOES NOT MEET ANIMAS¿S CRITERIA FOR AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329909 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR