BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2233488 · Received September 2, 2011

    Report

    Report Number
    2531779-2011-06459
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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: A REVIEW OF THE BLACK BOX HISTORY SHOWED THAT REBOOTING HAD OCCURRED. THERE WERE NO ALARMS RELATED TO THE COMPLAINT IN THE PUMP ALARM HISTORY. NO DAMAGE WAS FOUND TO BE BATTERY COMPARTMENT OR CAP. THE BATTERY CAP ATTACHED SECURELY TO THE PUMP AND THE PUMP POWERED ON NORMALLY. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ALARMS OR POWER ISSUES. THE BATTERY CAP WAS TESTED AND NO CONNECTION DEFECTS WERE FOUND. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE POWER CIRCUIT.

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN 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

    THE PATIENT CLAIMED THAT THE ANIMAS PUMP IS CONTINUALLY REBOOTING WHEN SHE ATTEMPTS TO PRIME. THERE WAS NO PRODUCT MISUSE. THE BATTERY CAP AND COMPARTMENT WAS NOT DAMAGED. THE BATTERY COMPARTMENT WAS CORROSION FREE. THE BATTERY WAS REPLACED BUT THE ISSUE WAS NOT RESOLVED WITH TRAINING. THE PRODUCT WAS SENT BACK FOR INVESTIGATION. THERE WAS NO REPORT OF ANY PATIENT IMPACT ASSOCIATED WITH THE COMPLAINT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE 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 18 YR