BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3102561 · Received May 9, 2013

    Report

    Report Number
    2531779-2013-06095
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 SUBMITTED: (B)(4) 2013. THE ORIGINAL COMPLAINT SENT ON THIS MFR. REPORT # 2531779-2013-06095 WAS SUBMITTED IN ERROR. THE COMPLAINT WAS ALREADY SUBMITTED BY THE MANUFACTURER OF THE GLUCOSE METER ON MFR. REPORT # 30028382007-2013-09899. THERE IS NO ALLEGED MALFUNCTION OR DEFECT OF THE PATIENT'S INSULIN PUMP AND THERE WAS NO USE ERROR OF THE INSULIN PUMP IDENTIFIED. THE PATIENT REPORTEDLY CONTINUED TO USE THE INSULIN FOR INSULIN DELIVERY WITHOUT ISSUE.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING LOW BLOOD GLUCOSE (BG) OF 60 MG/DL WITH SHAKINESS WHEN ON THE ELEVATOR AT WORK THAT MORNING. THE PATIENT REPORTED THAT SHE TREATED THE BG WITH 5 GLUCOSE TABLETS AND 20 MINUTES LATER, HER BG HAD RESPONDED BY ELEVATING TO 132 MG/DL. THE REPORTED LOW BG DOES NOT MEET ANIMAS' CRITERIA OF A REPORTABLE ADVERSE EVENT. THE PATIENT STATED SHE BELIEVED THE LOW BG WAS DUE TO INACCURATE READINGS FROM THE METER REMOTE WHICH CAUSED THE PATIENT TO BOLUS MORE INSULIN THAT SHE ACTUALLY NEEDED. THE PATIENT DECLINED TROUBLESHOOTING OF THE INSULIN PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGED BOLUSING MORE INSULIN THAT NEEDED WITH THE INSULIN PUMP AS A RESULT OF INACCURATE BG READINGS ON THE METER REMOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203115 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR