BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2823257 · Received November 7, 2012

    Report

    Report Number
    2531779-2012-13251
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    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 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE WAS NOT RETURNED. A RESERVED SAMPLE FROM THE SAME LOT NUMBER WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A 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.

    Description of Event or Problem · 1

    THE PATIENT'S NANNY CONTACTED ANIMAS ON (B)(6) 2012 TO REPORT AIR BUBBLES IN THE PUMP'S CARTRIDGE AND TUBING. AT THE TIME OF THE CALL, THE REPORTER STATED THE PATIENT HAD HAD HIGH BLOOD GLUCOSE (BG) READINGS IN THE 160 - 300 MG/DL SINCE (B)(6) 2012. THE REPORTER DENIED THAT THE PATIENT DEVELOPED ANY SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA, ALTHOUGH MENTIONED THE PATIENT APPEARED 'PALE AND ILL LOOKING.' DURING THE CALL, THE REPORTER INFORMED CUSTOMER SUPPORT THAT THE PATIENT HAD A COUGH/COLD FOR THE PAST 3 WEEKS AND WAS EXPERIENCING AN INFECTED SITE ISSUE. THE PATIENT'S NANNY REPORTED THAT THE PATIENT'S HCP WAS CONTACTED (DATE NOT PROVIDED) AND RECOMMENDED ADJUSTMENTS TO THE PATIENT'S PUMP SETTINGS. PER THE REPORTER, THE PATIENT'S HCP ADJUSTED THE PATIENT'S BASAL RATE AND I:C RATIO. THE REPORTER CLAIMED THAT THE PATIENT'S HIGHER THAN NORMAL BG'S CONTINUED DESPITE THE PUMP ADJUSTMENTS. AT THE TIME OF TROUBLESHOOTING, THE REPORTER CONFIRMED THAT THE CARTRIDGE AND TUBING APPEARED IN GOOD CONDITION. THE REPORTER CONFIRMED THE CARTRIDGE WAS FILLED WITH ROOM TEMPERATURE INSULIN. IT WAS NOTED THAT THE REPORTER WAS USING THE CORRECT TECHNIQUE TO FILL THE CARTRIDGE. THE REPORTER STATED SHE WAS ABLE TO PRIME THE AIR BUBBLES OUT; HOWEVER, THE FOLLOWING DAY WOULD NOTICE MORE. THE ALLEGED ISSUE REMAINED UNRESOLVED. THE PATIENT'S REPORTED BG READINGS DO NOT MEET ANIMAS' CRITERIA OF A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART B201818

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR