BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2810353 · Received October 31, 2012

    Report

    Report Number
    2531779-2012-12976
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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 12/27/2012-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX AND PUMP HISTORIES DID NOT SHOW ANY UNUSUAL ALARMS. THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE ADVANCED FEATURES WERE FOUND TO BE FUNCTIONING APPROPRIATELY. THE BOLUS HISTORY WAS FOUND TO BE ACCURATE. THE PUMP AND A TEST METER WERE SUCCESSFULLY PAIRED FOR INVESTIGATION. ALL KEYPAD BUTTONS WERE FOUND TO BE FUNCTIONING APPROPRIATELY. THE PUMP AND METER WERE EXERCISED FOR 24 HOURS WITH PERIODIC BOLUSES EXECUTED DURING TESTING. THE BOLUSES PERFORMED DURING TESTING WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THERE WAS EVIDENCE OF MOISTURE CORROSION OBSERVED INSIDE THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE REPORTER CONTACTED ANIMAS TO REPORT THAT ON AN UNSPECIFIED DATE, THE PATIENT NOTED THE REPORTED PUMP WAS ALARMING AND BEEPING AFTER IT HAD BEEN EXPOSED TO MOISTURE IN A SWIMMING POOL. THE PATIENT ALSO NOTED MOISTURE IN THE PUMP. THERE WAS NO DAMAGE TO THE PUMP CASING OR BATTERY CAP, THE BATTERY CAP WAS SECURE AND THERE WAS NO DAMAGE TO THE KEYPAD. THE ISSUE WAS NOT RESOLVED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR