BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2122170 · Received June 13, 2011

    Report

    Report Number
    2531779-2011-04085
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT REBOOTING HAD OCCURRED. NO DAMAGE WAS FOUND TO THE BATTERY COMPARTMENT. THE BATTERY CAP THREADS WERE FOUND TO BE STRIPPED. THE BATTERY CAP WAS UNABLE TO MAINTAIN ELECTRICAL CONNECTION WITH THE PUMP. A TEST CAP WAS USED FOR EVALUATION. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER LOSS OR RE-BOOTING. UNRELATED TO THE EVENT EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED.

    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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE WENT SWIMMING AND THE PUMP LOST POWER. HE DENIED ANY CRACKS OR DAMAGE TO THE PUMP. THE PATIENT INSISTED THAT THE BATTERY CAP WAS REPLACED 3 MONTHS AGO. HE REPORTED THAT THE YELLOW O-RING ON THE BATTERY CAP HAD BEEN VISIBLE FOR SEVERAL DAYS. THE PUMP REPORTEDLY POWERED ON BUT THE TIME AND DATE RETURNED TO DEFAULT. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PUMP LOST POWER WITHOUT PHYSICAL DAMAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR