BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3231232 · Received July 17, 2013

    Report

    Report Number
    2531779-2013-11067
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/11/2013 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. THE INSIDE AND OUTSIDE OF PUMP SHOWED NO HEAT DAMAGE. INVESTIGATORS PERFORMED PUMP REWIND, LOAD, AND PRIME WITH NO LOSS OF POWER AND THE PUMP DID NOT GET HOT. THE PUMP WAS EXERCISED FOR 24 HRS. ON A 1 UNIT PER HOUR BASAL PROGRAM WITH NO LOSS OF POWER AND THE PUMP DID NOT GET HOT. ALL CURRENT READINGS WERE WITHIN SPECIFICATIONS. OPENED PUMP AND REMOVED FROM CASE. THERE WAS NO DEFECT FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A TEMPERATURE (TEMPERATURE ISSUE) ISSUE. THE REPORTER STATED THAT THE PUMP FELT HOT TO THE TOUCH. 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
    331461 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR