BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2193497 · Received August 5, 2011

    Report

    Report Number
    2531779-2011-05643
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    July 6, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 SUBMITTED: 09/05/2012 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED REBOOTS RECORDED IN THE BLACK BOX. ON EXAMINATION, THERE WAS NO DAMAGE FOUND TO THE BATTERY CAP OR BATTERY COMPARTMENT. THE BATTERY CAP THAT WAS RETURNED WITH THE PUMP ATTACHED SECURELY TO THE PUMP AND WAS FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT POWER ISSUES OR ALARMS OCCURRING. THE PUMP COVER WAS REMOVED FOR INVESTIGATION WITH NO DAMAGE NOTED TO THE POWER CIRCUIT. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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. (B)(6).

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THE ANIMAS PUMP HAS A POWER ISSUE. THE ANIMAS REPRESENTATIVE HAS LEFT A VOICEMAIL FOR THE PATIENT TO CONTACTED ANIMAS BACK TO COMPLETE A TROUBLESHOOTING SESSION. HOWEVER, THE PATIENT HAS NOT CONTACTED ANIMAS BACK. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THE ALLEGED ISSUE. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO AN ALLEGED POWER ISSUE.

    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