BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4233892 · Received November 6, 2014

    Report

    Report Number
    2531779-2014-31829
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 01/28/2015 ¿ DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/13/2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT ¿NO CARTRIDGE DETECTED¿ WARNINGS WERE RECORDED. DURING TESTING, THE PUMP FAILED TO RECOGNIZE THE CARTRIDGE DURING THE LOAD STEP. THE FORCE SENSOR CALIBRATION READING WAS FOUND TO BE OUT OF THE REQUIRED SPECIFICATIONS. THE PUMP CASE WAS REMOVED AND CONTAMINATION WAS FOUND ON THE FORCE SENSOR SHIM. THE FORCE SENSOR RESISTANCE READING WAS FOUND TO BE OUT OF THE REQUIRED SPECIFICATIONS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY WAS DIM AND THE DISPLAY TEXT WAS DISCOLORED. ALSO UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED ALONG THE SIDE OF THE PUMP AND CRACKED FROM THE BUMPER PAD TO THE CASE SEAL.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (UNABLE TO PRIME) ISSUE. THE DISTRIBUTOR ALLEGED THAT THE PUMP WOULD NOT PRIME. 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
    713813 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1