BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3809372 · Received May 13, 2014

    Report

    Report Number
    2531779-2014-13490
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Report Date
    May 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 - SUBMISSION DATE (B)(4) 2014; CORRECTION TO: THE CORRECT BRAND NAME IS ANIMAS INSULIN CARTRIDGE. THE CORRECT COMMON DEVICE NAME IS INSULIN PUMP CARTRIDGE. THE CORRECT MODEL# IS ANIMAS IR1200/1250/2020/OTP CART; THE CORRECT SERIAL# IS NI. THE CORRECT PMA/510(K) # IS K032257. THE CORRECT DEVICE MANUFACTURING DATE IS UNK. THE CORRECT LABELED FOR SINGLE USE IS ¿YES¿. THE CORRECT DEVICE IS ¿THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION¿.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. REPORTEDLY, THE PATIENT HAD RECURRING LOSS OF PRIME ALERTS. THE PATIENT STATED THAT THERE WAS NO SUDDEN CHANGE IN FORCE OR TEMPERATURE AND THE CARTRIDGE CAP WAS SECURED. REVIEW OF CARTRIDGE USAGE TECHNIQUES INDICATED THAT THE INSTRUCTION FOR USE WAS FOLLOWED.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
    286325 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR