BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3202789 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09555
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/16/2013 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. COMPLAINT REGARDING IOB COULD NOT BE DUPLICATED. WHEN REVIEWING THE PUMP BASAL HISTORY FOR (B)(6) 2013, IT WAS NOTED THE BASAL SEGMENTS WERE RECORDED OUT OF TIME SEQUENCE THE BLACK BOX FOR (B)(6) 2013 WAS NO LONGER AVAILABLE DUE TO THE USER OVERRIDING THE DATA. USING THE PATIENTS BASAL SETTINGS AND IOB SETTINGS A 14.1 UNIT BOLUS WAS PROGRAMMED AND DELIVERED .IOB AFTER BOLUS REGISTERED 14.1 UNITS AND DEPLETED TO 1.0 UNIT AFTER 2.5 HOURS. IOB AFTER 3.5 HOURS REGISTERED 0 UNITS. IT HAS BEEN DETERMINED BASED ON THE BASAL HISTORY THE PUMP TIME WAS MANIPULATED OR INCORRECTLY CHANGED DURING THE IOB ANOMALY THE USER EXPERIENCED. 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 DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/16/2013 WITH THE FOLLOWING FINDINGS: INVESTIGATORS WERE UNABLE TO DUPLICATE THE REPORTED COMPLAINT; BOLUSES ARE ACCURATELY RECORDING IN THE PUMP HISTORY. UNRELATED TO COMPLAINT A TORN KEYPAD WAS OBSERVED AND THE DISPLAY LENS WAS FOUND TO BE SCRATCHED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THE REPORTER STATED THAT THE PUMP WAS NOT RECORDING BOLUS AMOUNTS IN THE PUMP'S HISTORY AND CONFIRMED THAT THE TIME AND DATE WERE CORRECT. 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
    301073 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR