BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3912124 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-18996
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 19, 2014
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)-DEVICE EVALUATION: A RETAINED CARTRIDGE WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A RETAIN SAMPLE FROM THE SAME LOT NUMBER WAS TESTED. NO FAILURES WERE OBSERVED DURING THE CARTRIDGE LOT REVIEW. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A FILL TEST WAS PERFORMED WITH NO FAILURES OBSERVED; A LEAK TEST WAS PERFORMED WITH NO LEAKS OBSERVED. THE CARTRIDGE FORCE READINGS WERE CONFIRMED TO BE WITHIN SPECIFICATIONS; NO FAILURES WERE NOTED RELATED TO THE LOSS OF PRIME COMPLAINT. 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

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT CONTACTED ANIMAS AND ALLEGED THAT AFTER RECEIVING MULTIPLE LOSS OF PRIME WARNINGS SHE HAD ACCIDENTALLY PRIMED WHILE ATTACHED TO THE PUMP, AND OVER THE LAST 4 HOURS HAD INFUSED 19.3 UNITS. PATIENT HAD DISCONTINUED THE PUMP AND SELF TREATED WITH FOOD AND DRINK PRIOR TO CALL. HER BLOOD GLUCOSE (BG) WAS 174 MG/DL, NO SYMPTOMS. CUSTOMER SUPPORT ADVISED PATIENT TO CONTACT HCP OR 911 IMMEDIATELY. DURING A FOLLOW-UP CALL WITH CS ON 06/30/2014, THE PATIENT REPORTED SHE HAD BEEN ABLE TO TREAT AT HOME WITH FOOD/DRINK AND HER BG NEVER DROPPED LOW. THE BLOOD GLUCOSE EVENT IS NOT BEING REPORTED AS THE BG EXCURSION DOES NOT MEET THE ANIMAS REPORTABILITY CRITERIA FOR AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED AS THE LOSS OF PRIME ISSUE WITH THE CARTRIDGES WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390263 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR