BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2764456 · Received September 28, 2012

    Report

    Report Number
    2531779-2012-11431
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Report Date
    September 4, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE BLACK BOX REVIEW SHOWS ONE NO CARTRIDGE DETECTED WARNING. THE PUMP BOOTS TO VERIFY SCREEN SUCCESSFULLY. THE REWIND STEP PERFORMED AND DURING THE FIRST LOAD STEP ATTEMPT THE PISTON FAILED TO RECOGNIZE THE CARTRIDGE AT THE MOMENT OF CONTACT AND THE PUMP PUSHES AROUND A QUARTER OF TANK OF INSULIN BEFORE IT STOPS. THE FORCE SENSOR CALIBRATION READING WAS FOUND WITHIN SPECIFICATIONS. THE PUMP WAS OPENED AND THERE WERE NO DEFECTS FOUND ON THE FORCE SENSOR FLEX PINS AND CONTAMINATION WAS FOUND ON THE SENSOR PLATE. THE FORCE SENSOR RESISTANCE IS WITHIN SPECIFICATIONS. FURTHER INSPECTION FOUND EVIDENCE OF CONTAMINATION ON THE LEAD SCREW PASSING THE BALL SEAL LEVEL PREVENTING IT FROM MOVING FREELY.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2012. DEVICE EVALUATION: A RETAINED CARTRIDGE SAMPLE FROM LOT # B201837 WAS EVALUATED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FILL TEST, AND FORCE TEST WAS PERFORMED WITH NO FAILURES OBSERVED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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. CORRECTION NUMBER: 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PUMP DISPENSED INSULIN DURING THE LOAD STEP OF A CARTRIDGE CHANGE. A REVIEW OF THE PRIME HISTORY INDICATED SMALL PRIME VOLUMES OVER THE LAST 3 DAYS, INDICATING THAT INSULIN WAS BEING DISPENSED DURING THE LOAD STEP. THE PATIENT CONFIRMED THAT SHE WAS DISCONNECTED FROM THE PUMP AT THE TIME OF THE REPORTED INCIDENT. 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
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR