BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2708331 · Received August 21, 2012

    Report

    Report Number
    2531779-2012-08983
    Event Type
    Malfunction
    Date Received
    August 21, 2012
    Report Date
    July 26, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PUMP BLACK BOX SHOWED EVIDENCE OF MULTIPLE REPLACE BATTERY ALARMS. DURING TESTING, THE REWIND STEP THE PUMP EMITTED A CS 078-0008 ALARM. THE PUMP WAS UNABLE TO BE EXERCISED FOR 24 HOURS DUE TO CS 078-0008 ALARMS. THE PUMP WAS OPENED AND AN OPEN CIRCUIT WAS FOUND ON THE PUMP'S PRINTED CIRCUIT BOARD.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THE ANIMAS INSULIN PUMP HAS POWER ISSUES. THE SUBJECT PUMP ALLEGEDLY WILL NOT POWER ON. THE SUBJECT PUMP DID NOT HAVE PHYSICAL DAMAGE OR MOISTURE WITHIN. THERE WAS NO EVIDENCE OF PRODUCT MISUSE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS 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 46 YR