BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2562487 · Received May 7, 2012

    Report

    Report Number
    2531779-2012-03859
    Event Type
    Malfunction
    Date Received
    May 7, 2012
    Report Date
    April 8, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. THE SUBJECT CARTRIDGE WAS NOT SAVED BY THE PATIENT'S FATHER.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 07/05/2012-DEVICE EVALUATION: A RETAIN CARTRIDGE SAMPLE FROM LOT # B201780 HAS BEEN EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS PERFORMED WITH NO FAILURES OBSERVED. 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

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS ON BEHALF OF HER DAUGHTER (THE PATIENT) ALLEGING A CARTRIDGE CONNECTION ISSUE. THE REPORTER DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE ALLEGED ISSUE. THE REPORTER CLAIMED THAT ON (B)(6) 2012, THE PATIENT'S FATHER WENT TO LOOK A THE PUMP TO PERFORM A CORRECTIVE BOLUS AT AN UNSPECIFIED TIME. AT THAT MOMENT, THE PATIENT'S FATHER NOTICED THAT THE CARTRIDGE CAP WAS LOOSE. HE TOOK OFF THE CAP AND THE TUBING REPORTEDLY FELL OFF OF THE PUMP. THE REPORTER INDICATED THAT THE PUMP SHOWED THAT 78 UNITS OF INSULIN REMAINED IN THE CARTRIDGE. HOWEVER, THE REPORTER CLAIMED THAT THE CARTRIDGE HAD APPROXIMATELY THE SAME AMOUNT OF AIR IN IT. THE PATIENT'S FATHER CHANGED OUT THE CARTRIDGE AND MADE SURE THE TUBING WAS TIGHTENED PROPERLY. THE CARTRIDGE WAS NOT SAVED. HE ALSO MADE SURE THE CARTRIDGE CAP WAS SECURE. HE WAS UNSURE IF THE CARTRIDGE, WHICH WAS REPLACED, HAD ANY CRACKS. THE PATIENT'S PARENTS WERE INSTRUCTED BY THE ANIMAS REPRESENTATIVE INVOLVED IN THIS CONTACT ON PROPER CYCLING, INSPECTION, AND USE OF THE CARTRIDGES. THE PATIENT'S PARENTS WERE GOING TO MONITOR THE FUNCTIONING OF THE PUMP AND CALL BACK FOR ANY ISSUES. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MOTHER REPORTED A POSSIBLE CARTRIDGE AIR BUBBLE/LEAK ISSUE. HOWEVER, THERE IS NO EVIDENCE THAT THE PUMP CONTRIBUTED TO A SERIOUS INJURY. THE REPORTER DID NOT REPORT ANY BLOOD GLUCOSE READINGS, SYMPTOMS, AND/OR TREATMENT SUGGESTIVE OF 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 B201780

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR