BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3222404 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10399
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE NOT YET BEEN RETURNED. IF THE PRODUCT(S) ARE RETURNED, ANM WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 09/19/2013-DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 8/29/2013 WITH THE FOLLOWING FINDINGS: THE RUBBER KEYPAD WAS FOUND TO BE PEELING AT THE OK BUTTON. ALL THE BUTTONS WERE RESPONDING TO PRESSES PROPERLY. NO CONTAMINATION OR DAMAGE TO THE BUTTON CONTACTS WAS FOUND UPON REMOVAL OF THE RUBBER KEYPAD. VISUAL INSPECTION DID NOT SHOW MOISTURE INGRESS. A LEAK AT THE KEYPAD WAS OBSERVED WHEN LEAK TEST WAS PERFORMED. MOISTURE WAS FOUND THROUGHOUT THE PUMP UPON OPENING OF THE PUMP CASING.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING INTERMITTENT CHANGES IN THE PUMP KEYPAD. AFTER EXPOSURE TO MOISTURE, THE "OK" BUTTON IS COMPLETELY UNRESPONSIVE. ALL BUTTONS ON THE KEYPAD ARE INTERMITTENTLY UNRESPONSIVE. 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
    323471 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR