BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2278572 · Received October 6, 2011

    Report

    Report Number
    2531779-2011-07374
    Event Type
    Malfunction
    Date Received
    October 6, 2011
    Date of Event
    September 8, 2011
    Report Date
    September 8, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBER: 2531779-03/24/2010-003-R. THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION 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. TWO CARTRIDGES OF LOT NUMBERS B201689 AND B201700 WERE RETURNED WITH THE PUMP AND INVESTIGATED ON 09/29/2011. A VISUAL INSPECTION OF EACH CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A FORCE TEST WAS PERFORMED ON BOTH CARTRIDGES 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

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED A DISLODGED DISPLAY SCREEN AND FULLY DISLODGED FORCE SENSOR PINS. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH WAS DUPLICATED DURING TESTING. DURING TESTING THE LOAD STEP FAILED TO RECOGNIZE THE FILLED CARTRIDGE AND EMITTED A "NO CARTRIDGE DETECTED" WARNING.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PUMP DISPENSED INSULIN DURING THE LOAD STEP OF A ROUTINE CARTRIDGE WITH TWO DIFFERENT CARTRIDGES. THERE WAS NO REPORTED PATIENT IMPACT AS A RESULT OF THE INCIDENT.

    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 51 YR