BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2797794 · Received October 19, 2012

    Report

    Report Number
    2531779-2012-12541
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Report Date
    September 21, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2012 DEVICE EVALUATION: A RETAINED CARTRIDGE SAMPLE FROM LOT # B201835 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY-USER/PATIENT CONTACTED ANIMAS (ANM) ALLEGING CARTRIDGE AIR BUBBLE ISSUE. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE. THE PATIENT CLAIMED THAT WITH HER LAST 3 CARTRIDGE CHANGES, SHE HAD NOTICE A BIG BUBBLE IN THE CARTRIDGE. THE PATIENT DENIED OBSERVING ANY AIR BUBBLES IN THE CARTRIDGE AT THE TIMES THE CARTRIDGES WERE INSERTED INTO THE PUMP. THE PATIENT INDICATING THAT SHE WAS USING INSULIN AT ROOM TEMPERATURE. THE PATIENT NOTED THAT THE TUBING AND CARTRIDGE CONNECTION WAS TIGHT. SHE WAS REPORTEDLY FILLING THE CARTRIDGE(S) CORRECTLY. THE PATIENT WAS SENT REPLACEMENT PRODUCT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE HAD A CARTRIDGE AIR BUBBLE ISSUE. HOWEVER, THERE IS NO EVIDENCE THAT THE ALLEGED CARTRIDGE ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE READINGS, SYMPTOMS, AND/OR TREATMENT SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR