BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2150428 · Received July 6, 2011

    Report

    Report Number
    2531779-2011-04691
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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. 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

    (B)(4). DEVICE EVALUATION: 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 OCCURRED ON (B)(6) 2011. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTIONS OCCURRING. EVALUATION CONFIRMED THAT THE BATTERY CAP AND BATTERY COMPARTMENT ARE INTACT. THE COMPLAINT COULD NOT BE DUPLICATED ON INVESTIGATION.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PUMP HAS REBOOTED TWICE IN THE PAST TWO DAYS WITHOUT USER INTERVENTION. SHE STATED THE BATTERY WAS CHANGED AFTER THE FIRST REBOOT ON (B)(6) 2011, AND THE PUMP REBOOTED AGAIN ON (B)(6) 2011. SHE DENIED MOISTURE OR CORROSION IN THE BATTERY COMPARTMENT, AND STATED THAT THERE WAS NO STRUCTURAL DAMAGE TO THE BATTERY CAP AND COMPARTMENT. THE FAMILY MEMBER CONFIRMED THAT THE BATTERY CAP WAS CHANGED WITHIN THE LAST FOUR TO SIX MONTHS, AND THAT THE CAP TIGHTENS SECURELY TO THE PUMP WITH NO YELLOW O-RING VISIBLE. SHE STATED THAT THE PATIENT HAS NOT EXPERIENCED ANY BLOOD GLUCOSE EXCURSIONS RELATED TO THE REBOOTING.

    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 16 YR