BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2595939 · Received June 1, 2012

    Report

    Report Number
    2531779-2012-04781
    Event Type
    Injury
    Date Received
    June 1, 2012
    Report Date
    May 3, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A RESERVED SAMPLE FROM THE SAME LOT NUMBER B201779 WAS TESTED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED WITH NO DAMAGE OR DEFECTS NOTED. A FORCE TEST, FILL TEST AND LEAK TEST WERE 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 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS ON BEHALF OF HER DAUGHTER (THE PATIENT) AND REPORTED ELEVATED BLOOD GLUCOSE (BG) LEVELS. THE REPORTER INDICATED THAT THE PATIENT'S BG ROSE TO "300 MG/DL" ON (B)(6) 2012, WITH SYMPTOMS OF A HEADACHE AND SLIGHT NAUSEA. THE PATIENT CORRECTED FOR THE ELEVATED BG LEVEL AND CHANGED HER SITE. THE REPORTER ALSO CORRECTED VIA SYRINGE AND THE PATIENT'S BG RESPONDED TO "51 M//DL" BY THE LATE AFTERNOON. THE REPORTER INSERTED A NEW SITE AND THE PATIENT'S BG LEVEL INCREASED TO "155-160 MG/DL" BY THE NIGHTTIME. WHEN THE PATIENT WOKE UP, HIS BG LEVEL WAS "200 MG/DL". THE BG LEVEL EVENTUALLY INCREASED TO "490 MG/DL" AT AN UNSPECIFIED TIME. NO SYMPTOMS OF HYPERGLYCEMIA WERE REPORTED DURING THIS TIME. THE REPORTER TREATED THE PATIENT VIA SYRINGE JUST PRIOR TO CONTACTING ANIMAS. DURING TROUBLESHOOTING, THE REPORTER PULLED THE SITE AND NOTICED AN AIR BUBBLE IN THE TUBING. THE PATIENT WAS REPORTEDLY NOT USING INSULIN AT ROOM TEMPERATURE. THE ANIMAS REPRESENTATIVE INVOLVED IN THIS CONTACT INSTRUCTED THE REPORTER TO FILL NEW CARTRIDGES USING INSULIN AT ROOM TEMPERATURE AND TO USE SLOW, METHODICAL TECHNIQUE FOR TIGHTENING CONNECTIONS. THE REPRESENTATIVE ALSO NOTED THAT THERE WAS NO EVIDENCE TO INDICATE THAT THE PUMP WAS NOT DELIVERING INSULIN AS PROGRAMMED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED AN ELEVATED BG LEVEL WITH SYMPTOMS SUGGESTIVE OF SEVERE HYPERGLYCEMIA. HOWEVER, THE PATIENT'S INJURY CAN BE ATTRIBUTED TO POSSIBLE USE-ERROR CONSIDERING INSULIN THAT WAS NOT A ROOM TEMPERATURE WAS BEING USED AND AN AIR BUBBLE WAS FOUND IN THE TUBING. THERE IS NO EVIDENCE OF A PUMP ISSUE.

    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 B201779

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening