BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3223630 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10438
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANIMAS HAS REQUESTED THE SUBJECT PRODUCTS TO BE RETURNED FOR EVALUATION HOWEVER THE PRODUCTS HAVE NOT YET BEEN RETURNED OR EVALUATED. IF ANIMAS RECEIVES THE PRODUCT ANIMAS WILL INFORM THE FDA OF ANY PRODUCTS THAT FAIL EVALUATION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/02/2013 WITH THE FOLLOWING FINDINGS: THE PUMP BLACK BOX SHOWED THAT MULTIPLE POWER EVENTS HAD OCCURRED ON (B)(6) 2013. THE BATTERY COMPARTMENT AND CAP WERE FOUND TO BE INTACT. THE BATTERY CAP ATTACHED SECURELY TO THE PUMP AND THE PUMP POWERED ON AND WAS EXERCISED FOR 24 HOURS WITHOUT POWER LOSS OR ALARMS. A PUMP LEAK TEST WAS PERFORMED WITH NO LEAKS FOUND. THE PUMP WAS OPENED AND EVIDENCE OF MOISTURE WAS FOUND INSIDE OF THE PUMP. 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

    FOLLOW UP #2 10/02/2013 CORRECTION. THE DATE OF EVALUATION BY PRODUCT ANALYSIS SHOULD REFLECT 09/10/2013.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER STATED SHE WAS SWIMMING WITH THE PUMP TODAY AND NOW SHE HAS NO DISPLAY OR AUDIBLE TONES. 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
    322333 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR