BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3133557 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07189
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED (B)(4) 2013:THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: PUMP PASSED TIME TEST. BLACK BOX REVIEW SHOWS NO ACTIVITY OUTSIDE OF NORMAL USE. PUMP POWERS ¿ON¿ AND DISPLAYS ¿VERIFY¿ SCREEN. PUMP WAS EXERCISED FOR 5 DAYS ON 0.5U/H, NO TIME ISSUE OCCURRED DURING TESTING. PUMP WAS POWERED ¿OFF¿ ON (B)(4) 2013 FOR 70 MIN; THE UNIT WAS ABLE TO MAINTAIN TIME/DATE SETTINGS WITH A 3 SEC TOLERANCE. -THE PUMP WAS LEFT ¿OFF¿ FOR 7H, THE PUMP WAS UNABLE TO MAINTAIN TIME/DATE AND IT FLIPPED AFTER LESS THAN 24H OF ¿POWER ON REST¿. PUMP WAS OPENED AND DISASSEMBLED, BT1 COMPONENT WAS FOUND TO BE LEAKING.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (TIME AND DATE) ISSUE. REPORTEDLY, THE PATIENT NOTED THAT THE TIME AND DATE WERE INCORRECT ON THE PUMP AND HAD TO BE RESET TO THE CORRECT SETTING. IT WAS ALSO REPORTED THAT AFTER BATTERY CHANGES, THE TIME AND DATE RESET TO FACTORY DEFAULT. 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
    235693 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR