BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3012377 · Received March 20, 2013

    Report

    Report Number
    2531779-2013-02839
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP¿S BLACK BOX AND HISTORY WAS REVIEWED AND SHOWED NO EVIDENCE OF UNEXPLAINED POWER REBOOTS. NO DAMAGE WAS OBSERVED TO THE BATTERY COMPARTMENT OR THE RETURNED BATTERY CAP. THE RETURNED BATTERY CAP SECURELY TIGHTENED TO THE PUMP. THERE WERE NO CONNECTION DEFECTS OBSERVED. A 1.0 UNIT PER HOUR BASAL PROGRAM WAS EXECUTED IN THE PUMP FOR A 24 HOUR DURATION PERIOD USING THE RETURNED BATTERY; NO POWER INTERRUPTIONS OR WARNINGS WERE DUPLICATED DURING THIS TIME. THE BATTERY CAP HEIGHT AND WIDTH WERE FOUND TO BE WITHIN THE REQUIRED SPECIFICATIONS. THE PUMP COVER WAS REMOVED AND NO INTERNAL MOISTURE DAMAGE OR INTERMITTENT CONNECTIONS WERE OBSERVED. THE ORIGINAL ISSUE OF THE PUMP POWERING OFF WAS NOT DUPLICATED DURING INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE REPORTER STATED THAT THE PUMP WAS FREQUENTLY POWERING OFF WITHOUT ALARMING. 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
    116778 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR