BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2801031 · Received October 23, 2012

    Report

    Report Number
    2531779-2012-12621
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    September 24, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION COMPLETED (B)(4) 2012: TESTING REVEALED UNIDENTIFIED LOW FORCE WAS OBSERVED IN THE BLACK BOX BUT NOT REPRODUCED ON THE BENCH. BAD FORCE SENSOR CALIBRATION (LOW) AND A DAMAGED SPOKE SHIM WERE FOUND. AN "EZPRIME" OPERATION WAS PERFORMED WITH NO LOSS OF PRIME WARNINGS BEING DUPLICATED. UNITS REMAINING WERE CORRECTLY CALCULATED. REVIEW OF THE BLACK BOX SHOWS LOSS OF PRIME WARINGS ASSOCIATED WITH CARTRIDGE CHANGES AND UNIDENTIFIED LOW FORCE. THE PUMP WAS EXERCISED FOR 24HRS WITH NO LOSS OF PRIME WARNINGS BEING DUPLICATED. PUMP WAS OPENED AND EVALUATED. THE OLED DISPLAY AND FORCE SENSOR PINS ARE INTACT; NO DEFECT WAS FOUND WITH THE FORCE SENSOR FLEX PIN SOLDER. A DAMAGED SPOKE SHIM WAS FOUND DURING THE INVESTIGATION. THE FORCE SENSOR READS 6.5K AT 5LBS FORCE. ANIMAS HAD 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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 12/10/2012 DEVICE EVALUATION: THE INSULIN CARTRIDGE HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE INSULIN CARTRIDGE WAS 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.

    Description of Event or Problem · 1

    THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED BAD FORCE SENSOR CALIBRATION AND A DAMAGED SPOKE SHIM WHICH HAD NOT BEEN REPORTED BY THE USER. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON (B)(4) 2012.

    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