BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2895647 · Received January 3, 2013

    Report

    Report Number
    2531779-2013-00164
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Report Date
    December 11, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND IN THE PUMP OR THE METER. THE PUMP HISTORY SHOWS 1 EZBG BOLUS AND 7 NORMAL BOLUSES WERE PROGRAMMED BY THE METER ON (B)(6) 2012 AND ALL BOLUSES WERE FULLY DELIVERED. REVIEW OF THE METER HISTORY SHOW NO ERRORS RELATED TO THE COMPLAINT ON THE DATE OF THE EVENT. PUMP PAIRED SUCCESSFULLY WITH RETURNED METER. NO ERRORS OCCURRED DURING THE INVESTIGATION. PROGRAMMED AND SUCCESSFULLY COMPLETED A 10U EZBG AND 10U EZCARB BOLUS FROM THE METER, BOTH WERE CORRECTLY RECORDED IN THE PUMP HISTORY. A 10U NORMAL AND AUDIO BOLUS WERE ALSO COMPLETED AND ACCURATELY RECORDED IN PUMP HISTORY WITH NO ISSUES. UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND METER CONFIRMED THAT THEY WERE OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THE BOLUS HISTORY IS NOT RECORDING THE TYPE OF BOLUSES PROGRAMMED AND DELIVERED FROM THE METER REMOTE CORRECTLY. THE REPORTER STATED THAT THEY ONLY PROGRAM A EZCARB AND EZBG BOLUS BUT THE HISTORY INDICATES NO TYPE OF BOLUS FROM THE METER REMOTE ESPECIALLY ON (B)(6) 2012 WHEN THERE WERE SEVERAL BOLUSES PROGRAMMED AND DELIVERED. THERE WAS NO LOSS OF COMMUNICATION WARNINGS. THE REPORTER CONFIRMED THAT THE PUMP IS DELIVERING CORRECTLY. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2973 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR