BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3121649 · Received May 21, 2013

    Report

    Report Number
    2531779-2013-06784
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 25, 2013
    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 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY REVEALED DATA FROM THE REPORTED EVENT DATE WAS OVERWRITTEN. NO SUDDEN VOLTAGE DROPS WERE OBSERVED DURING INVESTIGATION. THE PUMP SUCCESSFULLY POWERED ON TO THE ¿VERIFY¿ SCREEN. THE PUMP WAS PRIMED AND EXERCISED WITH NO OVERHEATING OR ALARM ISSUES FOUND DURING TESTING. ALL CURRENT DRAWS WERE FOUND TO MEET REQUIRED SPECIFICATION WHEN TESTED WITH AN EXTERNAL POWER SUPPLY. THE PUMP WAS OPENED AND INSPECTED WITH NO INTERMITTENT ISSUES FOUND TO THE POWER CIRCUIT. 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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT IT LOOKS LIKE THE PUMP HAS MELTED. THE PATIENT WEARS PUMP CLIPPED TO HER WAIST ON HER BRA. THE PATIENT REPORTED THAT THE PUMP GETS WARM, BUT SHE DID NOT THINK IT WAS MELTING THE PUMP. THE PATIENT REPORTED THAT THE BATTERIES ARE WARM WHEN REMOVING. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE PUMP TEMPERATURE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224192 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR