BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2955057 · Received February 11, 2013

    Report

    Report Number
    2531779-2013-01677
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 - (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX HISTORY INDICATED A SUDDEN VOLTAGE DROP FROM 1.40 V TO 1.30 V OCCURRING ON (B)(6) 2013 RESULTING IN A "LOW BATTERY" ALARM. THERE WAS NO BATTERY OR BATTERY CAP RETURNED WITH THE PUMP FOR INVESTIGATION. THE PUMP POWERED ON NORMALLY AND WAS EXERCISED FOR 24 HOURS WITHOUT OVERHEATING OR ALARMING. THE PUMP ELECTRICAL CURRENT DRAWS WERE TESTED AND WERE FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP WAS OPENED AND THERE WAS NO INDICATION OF INTERNAL MOISTURE INGRESS OR INTERMITTENT CONNECTIONS IN THE POWER CIRCUIT. NO DEFECTS WERE FOUND RELATED TO THE COMPLAINT.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(4) 2013 REPORTING THAT AN HOUR BEFORE THEY CONTACTED CUSTOMER SUPPORT THE PUMP FELT WARMER THAN USUAL. THE PATIENT DENIED ANY MOISTURE EXPOSURE TO THE PUMP. THE PATIENT CONFIRMED THAT THE BATTERY COMPARTMENT WAS NOT DAMAGED. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE HOT PUMP ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58438 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR