BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2140562 · Received June 27, 2011

    Report

    Report Number
    2531779-2011-04478
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Report Date
    May 31, 2011
    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

    FOLLOW-UP #1 (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: NO PHYSICAL DAMAGE WAS FOUND TO THE BATTERY COMPARTMENT OR BATTERY CAP. THE PUMP BOOTED TO THE VERIFY SCREEN WITH APPROPRIATE ALARMS. A TEST BOLUS WAS PERFORMED WITH NO POWER LOSS OCCURING. A REVIEW OF THE BLACK BOX SHOWED A REBOOT JUST AFTER AN OCCLUSION ALARM ON THE REPORTED EVENT DATE; THE PUMP WAS POWERED ON BACK ON FOR EIGHT MINUTES AND EMITTED 3 NO PRIME WARNINGS. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT REBOOTING OR LOSING POWER. THE PUMP WAS OPENED AND THERE WERE NO DEFECTS TO THE POWER CIRCUIT. 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.

    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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PUMP WILL NOT TURN ON. THE PATIENT RECEIVED A CS ALARM A FEW DAYS AGO, SHE REBOOTED THE PUMP AND IT WORKED FINE. WHEN SHE WAS GIVING A BOLUS SHE RECEIVED AN OCCLUSION ALARM AND THEN THE POWER WAS OFF TO THE PUMP. SHE CHANGED THE BATTERY THREE TIMES AND THE PUMP WILL NOT TURN ON.

    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 23 YR