BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2904635 · Received January 9, 2013

    Report

    Report Number
    2531779-2013-00437
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 13, 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 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 DATE OF SUBMISSION 08/07/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/15/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP HISTORY WAS REVIEWED AND SHOWED THE DATES BEGINNING ON 06/08/2013. THE BLACK BOX AND HISTORIES FOR THE COMPLAINT ON 12/14/2012 HAVE BEEN OVERWRITTEN DUE TO CONTINUED USE OF THE PUMP. THERE WERE NO ALARMS ASSOCIATED WITH TO THE COMPLIANT RECORDED IN BLACK BOX OR ALARM HISTORY; ONLY TYPICAL USAGE WAS OBSERVED. THE USER¿S PROGRAMMED BASAL RATES WERE CORRECTLY REFLECTED IN THE DAILY INSULIN DELIVERY TOTALS. THE PUMP PASSED REQUIRED 29 HOUR FLOW ACCURACY TEST SUCCESSFULLY. THE COMPLAINT WAS NOT ABLE TO BE DUPLICATED. THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS TO REPORT AN ISSUE WITH ALLEGED INACCURATE DELIVERY WITH THE REPORTED INSULIN PUMP. THE TECHNICAL SUPPORT REPRESENTATIVE CONTACTED THE PATIENT TO TROUBLESHOOT THE PUMP; HOWEVER, WAS UNABLE TO REACH HIM BY TELEPHONE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE. AS THE ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12215 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR