BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3191030 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09042
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. DEVICE EVALUATION: REVIEW OF THE BLACK BOX DATA REVEALED MULTIPLE RECORDS OF ¿POWER ON RESET¿ ON (B)(6) 2013. ON EXAMINATION, THERE WAS EVIDENCE OF MOISTURE INSIDE THE BATTERY COMPARTMENT. DURING INVESTIGATION, POWER LOSS WAS NOT OBSERVED. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ANY ISSUES. A LEAK TEST REVEALED A LEAK AT THE DISPLAY LENS. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED EVIDENCE OF MOISTURE CONTAMINATION INSIDE THE PUMP. INVESTIGATION WAS UNABLE TO DUPLICATE THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE REPORTER STATED THAT THE PUMP WAS BLANK AT RANDOM. THE REPORTER STATED THAT THE PATIENT HAD A BG OF 200 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. 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
    289548 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR