BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2232199 · Received September 2, 2011

    Report

    Report Number
    2531779-2011-06427
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    August 5, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. (B)(4).

    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 HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. VISUAL INSPECTION CONFIRMED NO DAMAGE TO THE BATTERY CAP AND COMPARTMENT; THE BATTERY CAP WAS ABLE TO ATTACH SECURELY TO THE PUMP. THE PUMP POWERS ON NORMALLY WITH NO ALARMS, AND THERE WAS NO DAMAGE FOUND TO THE POWER CIRCUIT. NO DEFECTS WERE FOUND TO THE BATTERY CAP CONNECTIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OCCURRING.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT HE NOTICED THE PUMP SCREEN WAS BLANK. HE TOOK THE BATTERY OUT OF THE PUMP AND ATTEMPTED TO REBOOT; THE PUMP BEEPED BUT THE SCREEN REMAINED BLANK. HE TRIED TO INSERT A BATTERY FROM A DIFFERENT PACK AND AGAIN THE PUMP BEEPED BUT THE SCREEN REMAINED BLANK.

    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 7 YR