BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2819452 · Received November 5, 2012

    Report

    Report Number
    2531779-2012-13200
    Event Type
    Injury
    Date Received
    November 5, 2012
    Report Date
    October 7, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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)(6) 2012. DEVICE EVALUATION: A RETAINED CARTRIDGE SAMPLE FROM LOT # B201778 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 REPORTER CONTACTED ANIMAS (ANM) ON BEHALF OF HER DAUGHTER (THE PATIENT) ALLEGING A RECURRING LOSS OF PRIME ISSUE. THE REPORTER INDICATED THAT THE PATIENT HAD GOTTEN SEVERAL LOSS OF PRIME WARNINGS ON (B)(6) 2012. IN EACH CASE THE LOSS OF PRIME ALARM OCCURRED, THE PATIENT CLAIMED THAT SHE DISCONNECTED AND PRIMED THE TUBING. THE PATIENT DENIED THAT SHE SAW DROPS COMING OUT OF THE END FOR THE TUBING. THE LAST CARTRIDGE CHANGE WAS PERFORMED ON (B)(6) 2012, AT AN UNSPECIFIED TIME. ON (B)(6) 2012, THE PATIENT REPORTEDLY WOKE UP WITH AN UNSPECIFIED HIGH BLOOD GLUCOSE (BG) LEVEL. SHE ALSO REPORTEDLY HAD 2 BG'S ABOVE "500 MG/DL" DURING THE TIME OF CONCERN. THE REPORTER DENIED THAT THE PATIENT HAD KETONES. NO SYMPTOMS OR MEDICAL INTERVENTION WERE REPORTED BY THE REPORTER. THE REPORTER DENIED THAT THE CARTRIDGE CAP WAS LOOSE. SHE ALSO DENIED HAVING ANY POWER ISSUES. THE REPORTER INDICATED THAT THE PUMP DID NOT SUFFER ANY TRAUMA. NO PERTINENT ALARMS WERE OBSERVED IN THE PUMP'S HISTORY. THROUGH TROUBLESHOOTING, THE REPORTER PULLED OUT THE CARTRIDGE FROM THE PUMP AND WAS ABLE TO MANUALLY PRIME THE CARTRIDGE WITH VISIBLE DROPS APPEARING. THE REPORTER WAS ADVISED TO CHANGE OUT THE CARTRIDGE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED ELEVATED BG LEVELS SUGGESTIVE OF SEVERE HYPERGLYCEMIA. HOWEVER, AT THIS TIME, IT IS UNKNOWN IF THE CARTRIDGE, TUBING, USE-ERROR, AND/OR DIABETES MANAGEMENT FACTORS CONTRIBUTED TO THE PATIENT'S INJURIES.

    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 12 YR Life Threatening