BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3210974 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09753
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 09/12/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/23/2013 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP¿S HISTORY VERIFIED A 0 UNIT BOLUS ON 06/18/2013 A 1:14 AND A 14 UNIT BOLUS AT 11:21. DURING TESTING, THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO UNPROGRAMMED BOLUSES. THE PUMP WAS ABLE TO SUCCESSFULLY PERFORM A 10 UNIT AUDIO BOLUS AND A 10 UNIT NORMAL BOLUS; BOTH WERE ACCURATELY RECORDED IN THE PUMP¿S HISTORY. UNRELATED TO THE COMPLAINT, EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEYPAD BUTTON CONTACTS WHEN THE KEYPAD COVER WAS REMOVED DURING EVALUATION.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE: THE PUMP IS INDICATING THAT IT IS DELIVERING BOLUSES THAT THE PATIENT DID NOT PROGRAM. CUSTOMER SUPPORT ADVISED THE PATIENT TO GO TO AN ALTERNATE INSULIN DELIVERY METHOD. 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
    311056 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR