BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2864310 · Received December 10, 2012

    Report

    Report Number
    2531779-2012-14359
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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

    FOLLOW-UP #1 DATE OF SUBMISSION 01/21/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED AN 8 UNIT COMBO BOLUS ON THE REPORTED EVENT DATE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS SUCCESSFULLY PAIRED WITH A TEST METER. THE PUMP AND METER WERE EXERCISED FOR 24 HOURS WITH NO UNPROGRAMMED BOLUSES OCCURRING. PERIODIC BOLUSES WERE PROGRAMMED DURING TESTING USING THE NORMAL, EZ-CARB, EZ-BG, AND COMBO BOLUS FEATURES AND ALL BOLUSES WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THE KEYPAD BUTTONS WERE TESTED AND NO HYPERSENSITIVITY WAS FOUND. THE COMPLAINT COULD NOT BE DUPLICATED DURING INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THE PATIENT ALLEGED THAT A COMBO BOLUS WAS ADMINISTERED IN THE AMOUNT OF 8 UNITS OF INSULIN THAT SHE DID NOT PROGRAM INTO THE PUMP. THE PATIENT DENIED HAVING LOW BLOOD GLUCOSE AT THE TIME OF THE CALL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR