BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2912443 · Received January 12, 2013

    Report

    Report Number
    2531779-2013-00576
    Event Type
    Malfunction
    Date Received
    January 12, 2013
    Report Date
    December 15, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    FOLLOW-UP #1 02/13/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP BLACK BOX SHOWED NO EVIDENCE OF THE REPORTED POWER EVENT. THERE WAS NO DAMAGE FOUND TO BE BATTERY COMPARTMENT OR CAP. THE BATTERY CAP SECURED TO THE PUMP AND THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT POWER ISSUES. THE PUMP WAS OPENED AND NO INTERNAL DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2012, 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
    19356 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR