BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2946164 · Received February 6, 2013

    Report

    Report Number
    2531779-2013-01531
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Report Date
    January 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION PROCESS. A 10U AUDIO BOLUS AND NORMAL BOLUS WERE SUCCESSFULLY PERFORMED AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THE TOTAL DAILY INSULIN TOTALS ARE CONSISTENT WITH THE USERS PROGRAMMED BASAL RATE FOR A 24 HOUR PERIOD. THE BOLUS HISTORY SHOWS THE FOLLOWING BOLUSES ON (B)(6) 2013; A 5.95U AT 12:54 AND A 6.15U AT 23:38. NO HYPERSENSITIVE KEYS WERE OBSERVED ON THE KEYPAD. 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. 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) 2013 REPORTING THAT THE PUMP IS MISSING THE HISTORY OF BOLUSES GIVEN AND BLOOD GLUCOSE LEVELS. THE REPORTER ALSO STATED THAT THE HISTORY DOES NOT PRINT OUT IN THE (B)(6) REPORTS. 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
    50952 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR