BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3270682 · Received August 8, 2013

    Report

    Report Number
    2531779-2013-12640
    Event Type
    Injury
    Date Received
    August 8, 2013
    Report Date
    July 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. A RESERVED SAMPLE FROM THE SAME LOT NUMBER B201805 WAS TESTED BY PRODUCT ANALYSIS ON 08/28/2013 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED AND NO DAMAGE OR DEFECTS WERE NOTED. A FILL, FORCE AND LEAK TEST WAS PERFORMED WITH NO FAILURES. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS STATING SHE EXPERIENCED A BLOOD GLUCOSE (BG) VALUE IN THE RANGE OF 14MMOL/L TO 20MMOL/L WITH MODERATE THIRST AND MODERATE DROWSINESS. THE PATIENT STATED EVERY TIME THE CARTRIDGE WAS CHANGED, THE PUMP INDICATED THAT IT WAS NOT PRIMED. IT WAS NOTED THAT THE PATIENT CHANGED THE SITE/SET, BOLUSED VIA THE PUMP AND THE BG WENT DOWN TO 6.4MMOL/L. THE PATIENT REPORTEDLY BELIEVED THAT THE HIGH BG ISSUES HAD SOMETHING TO DO WITH PUMP ALARMING ¿LOSS OF PRIME¿. THE PATIENT DENIED THAT THE PUMP WAS DAMAGED. THE PATIENT REPORTEDLY CHANGED THE CARTRIDGE EVERY 3 DAYS AND THE CARTRIDGE CAP SECURED TIGHTLY TO THE PUMP. THE PATIENT STATED SHE DID NOT HAVE ANY CARTRIDGES ON HAND TO TROUBLESHOOT SINCE SHE WAS AT WORK. CS REVIEWED THE PUMP ALARM HISTORY; NO RELATED ALARMS WERE NOTED IN THE PUMP HISTORY. IT WAS NOTED AT THE TIME OF THE CALL WITH CUSTOMER SUPPORT (CS) THE PATIENT¿S BG WAS REPORTED TO BE 14MMOL/L. THE PATIENT REPORTEDLY CONTINUED INSULIN PUMP THERAPY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT. IT WAS NOT CLEAR WHAT THE CONTRIBUTING FACTORS WERE TO THE PATIENT'S REPORTED BG EXCURSION OR IF THERE WAS A DEVICE MALFUNCTION. ALTHOUGH, THE PATIENT BELIEVED THE BG EVENT HAD TO WITH THE MULTIPLE LOSS OF PRIME ISSUE. THE ALLEGED LOSS OF PRIME ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE PUMP WILL ALARM TO ALERT THE USER OF THE ISSUE. THE OWNER¿S BOOKLET INSTRUCTS THE USER TO BE PREPARED TO GIVE HIS OR HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON. THE PUMP EMITTED APPROPRIATE WARNINGS AND INSTRUCTIONS TO THE USER WHEN THE LOSS OF PRIME ISSUE OCCURRED. ADDITIONALLY, THERE WAS NO INDICATION OF A RELATED ALARM WHEN THE PUMP HISTORY WAS REVIEWED AND THE PATIENT REPORTEDLY WAS ABLE TO DELIVER INSULIN USING THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374670 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Life Threatening