BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2566571 · Received May 9, 2012

    Report

    Report Number
    2531779-2012-03963
    Event Type
    Malfunction
    Date Received
    May 9, 2012
    Report Date
    April 11, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION:FOLLOW-UP #1 SUBMITTED 8/062012. THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 7/12/2012 WITH THESE FINDINGS: EVALUATION REVEALED THAT THERE WAS BAD FORCE SENSOR CALIBRATION (LOW) AND AN INTERMITTENT FORCE SENSOR CONNECTION. AN EZPRIME OPERATION WAS PERFORMED AND DURING THE LOAD STEP PUMP DID NOT RECOGNIZE CARTRIDGE AND PUSHED ALL THE FLUID OUT 'NO CARTRIDGE DETECTED WARNING' EMITTED. THE PUMP DID NOT DETECT ANY FORCE AT 5 POUNDS AND KEPT LOADING DURING CALIBRATION TEST ON THE BENCH. THERE WERE NO ALARMS RELATED TO THE COMPLAINT IN THE ALARM HISTORY. REVIEW OF THE BLACK BOX SHOWS SEVERAL LOSS OF PRIME WARNINGS ASSOCIATED WITH ZERO FORCE AND "NO CARTRIDGE DETECTED" WARNINGS. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN HAD A REDDISH TINT TO IT AND WAS DIFFICULT TO READ. THE PUMP WAS OPENED AND A TEST DISPLAY WAS INSERTED; THE REDDISH TINT DID NOT TRAVEL TO THE TEST DISPLAY. ALL KEYPAD BUTTONS ARE INTERMITTENT WHEN PRESSED/DIFFICULT TO PUSH; A TEAR AT THE "UP" BUTTON WAS OBSERVED. CONTAMINATION AROUND ALL BUTTON CONTACTS WAS OBSERVED WHEN THE KEYPAD WAS REMOVED. THE PUMP WAS OPENED AFTER TESTING AND A CROOKED LED DISPLAY WAS OBSERVED. THE FORCE SENSOR FLEX PINS ARE PARTIALLY DISLODGED FROM THE PCB SOCKETS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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. CORRECTION # 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING THAT THE PUMP DISPENSED THE ENTIRE CARTRIDGE DURING THE LOAD CARTRIDGE STEP AND THE PUMP THEN EMITTED A NO CARTRIDGE DETECTED WARNING. THE PUMP HAS ALSO BEEN EMITTING LOSS OF PRIME WARNINGS. THIS REPORT IS BEING MADE BASED ON THE ALLEGED LOAD STEP MALFUNCTION.

    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 21 YR