BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2192480 · Received August 5, 2011

    Report

    Report Number
    2531779-2011-05634
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 10, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    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: NO ACTIVITY RELATED TO THE COMPLAINT WAS OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. THE BATTERY COMPARTMENT AND CAP SHOWED NO SIGNS OF DAMAGE AND NO EVIDENCE OF MOISTURE WAS OBSERVED IN THE PUMP. THE DISPLAY SCREEN WAS FOUND TO BE CRACKED. WHEN THE PUMP POWERED ON THE DISPLAY SCREEN REMAINED BLANK. THE PUMP WAS EXERCISED FOR A FEW MINUTES AND BEGAN TO GET WARM. THE PUMP CURRENT DRAW MEASURE HIGH. THE DISPLAY SCREEN WAS CHANGED OUT AND THE PUMP WAS FOUND TO HAVE NORMAL CURRENT DRAWS; THE PUMP WAS EXERCISED FOR EIGHT HOURS WITHOUT OVERHEATING.

    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.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PUMP WAS HOT. SHE DENIED TRAUMA TO THE PUMP. SHE CONFIRMED THAT THE BATTERY CAP WAS SECURE, AND THAT THERE WAS NO PHYSICAL DAMAGE TO THE BATTERY CAP AND COMPARTMENT. THERE WAS NO REPORTED INJURY TO THE PATIENT AS A RESULT OF THE REPORTED INCIDENT.

    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 12 YR