BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2180518 · Received July 27, 2011

    Report

    Report Number
    2531779-2011-05340
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. REVIEW OF THE PUMP HISTORY VERIFIED LOSS OF PRIME WARNINGS DURING THE LOAD STEP. THE PUMP WAS REWOUND, LOADED, AND PRIMED WITH NO ALARMS DURING INVESTIGATION. THE PUMP WAS EXERCISED WITH NO ALARMS OCCURRING. THE FORCE SENSOR CALIBRATION READING WAS OUT OF SPECIFICATION HOWEVER THE RESISTANCE READING WAS WITHIN SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    THE PATIENT CALLED TO REPORT THAT HE CHANGED HIS INFUSION SET AND WHEN HE PRIMED HIS PUMP HE ONLY PRIMED 9 UNITS. HE PREVIOUSLY PRIMED 21.6 UNITS ON (B)(6) AND 21.8 UNITS ON (B)(6) BUT ON (B)(6) HE ONLY PRIMED 9 UNITS TO SEE 5 DROPS OF INSULIN COMING OUT OF THE END OF THE TUBING. THE 9 UNITS IS AN UNEXPECTEDLY LOW AMOUNT OF INSULIN AND SHOULD NOT HAVE FILLED THE INFUSION SET TUBING. DURING TROUBLESHOOTING THE PATIENT LOADED THE CARTRIDGE AND PRIMED 2.7 UNITS. THE PUMP EMITTED A "PUMP IS NOT PRIMED" WARNING AND HE ALSO PRIMED 0.6 AND 3 UNITS. THE LOW PRIME VOLUME COULD BE DUE TO THE PUMP DISPENSING INSULIN INTO THE INFUSION SET TUBING DURING THE LOAD STEP. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    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 46 YR