BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2162315 · Received July 14, 2011

    Report

    Report Number
    2531779-2011-04949
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CARTRIDGE(S) HAS NOT BEEN RETURNED AT THIS TIME. THE RETAIN CARTRIDGE LOTS WERE EVALUATED. THE LOTS PASSED VISUAL INSPECTION. NO DAMAGE OR DEFECTS WERE NOTED TO THE LUER CONNECTION OR O-RINGS. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED. NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE. LOTS B201541 & B201629 WERE TESTED. BOTH LOTS PASSED THE LEAK TESTS. NO DEFECT WERE FOUND, THE COMPLAINTS WERE NOT CONFIRMED AND COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE PASSES VISUAL INSPECTION, NO DAMAGE OR DEFECTS WERE NOTED TO THE LUER CONNECTION OR O-RINGS. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE.

    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. LOT # B201541.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS ALLEGING A LEAKING CARTRIDGE ISSUE. THE PATIENT CLAIMED THAT ON AN UNSPECIFIED DATE/TIME SHE NOTICED THAT HER SHIRT WAS WET WHILE LYING IN BED. THE PATIENT REPORTEDLY DISCONNECTED FROM THE PUMP AND PULLED THE CARTRIDGE OUT. THE PATIENT CLAIMED THAT SHE NOTICED MOISTURE AND THE SMELL OF INSULIN COMING FROM THE CARTRIDGE COMPARTMENT. THE PATIENT DID NOT OBSERVE ANY LEAKING AT THE SITE. DUE TO THE ALLEGED ISSUE, THE PATIENT CLAIMED THAT HER BLOOD GLUCOSE (BG) LEVEL HAD BEEN ELEVATED. THE PATIENT REPORTED AN ACTUAL BG READING OF "495 MG/DL" AND MENTIONED THAT SHE SELF-TREATED WITH 15 UNITS OF INSULIN VIA SYRINGE. THE PATIENT DID NOT REPORT ANY SYMPTOMS. THE PATIENT STATED THAT THE TUBING WAS SECURE AT THE LUER LOCK. SHE DENIED OBSERVING ANY CRACKS. THE PATIENT ADMITTED TO SEEING AN AIR BUBBLE IN THE CARTRIDGE. SHE ALSO ADMITTED TO OCCASIONALLY SEEING BLEEDING AT HER SITE(S). THE ANIMAS REPRESENTATIVE INVOLVED IN THIS CONTACT INFORMED THE PATIENT THAT BLOOD CAN POTENTIALLY BLOCK THE DELIVERY OF INSULIN. HOWEVER, THE PATIENT INSISTED THAT THE ISSUE WAS NOT RELATED TO HER SITE(S) AND THAT IT WAS A CARTRIDGE ISSUE. THE PATIENT ALSO REFUSED TO CHANGE HER SITE DURING THE TROUBLESHOOTING PROCESS. THE PATIENT WAS ABLE TO DELIVER AN AIR BOLUS WITH NEW SUPPLIES AND CONFIRMED OBSERVING DROPS COMING OUT OF THE END OF THE TUBING. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED SHE HAD LEAKING CARTRIDGE. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE VALUES OR SYMPTOMS THAT MEET ANIMAS' CRITERIA FOR A SERIOUS INJURY.

    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 58 YR