BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4214062 · Received October 30, 2014

    Report

    Report Number
    2531779-2014-30901
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/17/2015 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT THREADS WERE CRACKED. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY WAS DIM AND DISCOLORED. ALSO UNRELATED, THE KEYPAD WAS TORN AND THE UP ARROW AND CONTRAST BUTTONS HAD AN INTERMITTENT RESPONSE. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS FOUND UNDER ALL OF THE BUTTON CONTACTS. THE UP ARROW BUTTON CONTACT WAS ALSO OBSERVED TO BE INVERTED. 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 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. 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. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER STATED THAT THERE WAS A CASING/CONDITION ISSUE. IT WAS REPORTED THAT THE BATTERY COMPARTMENT WAS DAMAGED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695490 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR