BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3802661 · Received May 9, 2014

    Report

    Report Number
    2531779-2014-13100
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 6, 2014
    Report Date
    May 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN REQUESTED FOR RETURN AT THIS TIME. 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 DISTRIBUTOR CONTACTED ANIMAS ALLEGING THAT THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL ON (B)(6) 2014 FOR ELEVATED BLOOD GLUCOSE (BG). THE PATIENT HAD REPORTEDLY ATTENDED A FUNCTION ON (B)(6) 2014 AND BGS HAD BEEN OVER 20 MMOL/L BUT THE REPORTER THOUGHT THE BGS HAD RESOLVED. HOWEVER, WHEN THE PATIENT RETURNED HOME FROM THE FUNCTION, THE PATIENT REPORTEDLY WAS ILL AND VOMITING, AND BGS WERE OVER 30 MMOL/L WITH HIGH KETONES. THE REPORTER NOTED THAT THE PATIENT¿S BGS EVENTUALLY CAME DOWN TO 14 MMOL/L AROUND 7:00 PM AFTER MULTIPLE BOLUSES. THE PATIENT WAS REPORTEDLY TAKEN TO THE HOSPITAL THE AFTERNOON OF (B)(6) 2014 BECAUSE KETONES WOULD NOT COME DOWN, AND WAS TRANSFERRED TO ANOTHER HOSPITAL ON (B)(6) 2014. THE REPORTER DID NOT SPECIFY HOW THE PATIENT WAS TREATED AT THE HOSPITAL. A DIABETES EDUCATOR HAD REPORTEDLY REVIEWED THE PUMP AND FOUND SOME INSTANCES OF 0-UNIT BASAL DELIVERY, BUT TROUBLESHOOTING DETERMINED THAT THE 0-UNIT BASAL DELIVERIES COINCIDED WITH TIMES THAT OCCLUSION ALARMS HAD BEEN EMITTED. THE PATIENT REPORTEDLY HAD BEEN TAKEN OFF THE PUMP THE AFTERNOON OF (B)(6) 2014 AND WAS PLACED ON ANOTHER PUMP, HOWEVER THE PATIENT¿S BGS REPORTEDLY DID NOT RESPOND QUICKLY TO BOLUSES FROM THE OTHER PUMP EITHER. THE PATIENT WAS REPORTEDLY DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014 AND WAS TO RESUME THE ORIGINAL PUMP; THE PATIENT¿S BG AT THE TIME OF DISCHARGE WAS REPORTEDLY 6 MMOL/L. A REVIEW OF THE PUMP¿S ALARM HISTORY SHOWED TWO OCCLUSION ALARMS THE MORNING OF (B)(6) 2014. TROUBLESHOOTING INDICATED THAT THE PATIENT HAD NOT PERFORMED A SITE CHANGE SINCE (B)(6) 2014 AND WAS ALSO RE-USING CARTRIDGES. IT WAS DETERMINED THAT MISUSE IN RE-USING SUPPLIES WAS A CAUSE OR CONTRIBUTOR IN THE ALLEGED INCIDENT. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED SEVERE HYPERGLYCEMIA RELATED TO MISUSE OF THE CARTRIDGE WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281544 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R