BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2210625 · Received August 12, 2011

    Report

    Report Number
    2531779-2011-05843
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A RETAIN CARTRIDGE SAMPLE FROM THE SAME LOT NUMBER WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FILL TEST, AND FORCE TEST WERE PERFORMED WITH NO LEAKS, AIR BUBBLES, OR 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. THERE WAS NO DEFECT FOUND ON INVESTIGATION; THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS AND IS NO LONGER AVAILABLE FOR REVIEW. THE PATIENT'S PHYSICIAN PHOTOGRAPHED THE CARTRIDGE AND SENT A COPY TO ANIMAS. THE PHOTOGRAPH SHOWS THAT A SECTION OF ONE OF THE BLACK O-RINGS THAT SITE ON THE TOP OF THE CARTRIDGE PLUNGER HAD BECOME DISLODGED FROM THE GROOVE IN WHICH IT NORMALLY SITS. TESTING ON THE RETAINED SAMPLE OF THE LOT NUMBER FROM WHICH THE CARTRIDGE CAME HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS FINISHED A SUPPLEMENTAL REPORT WILL BE FILED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE (BG) LEVELS ON (B)(6) 2011 AND DISCHARGED THE NEXT DAY. THE SEQUENCE OF EVENTS WAS REPORTED BY A FAMILY MEMBER. ON (B)(6) 2011 A FAMILY MEMBER CHANGED THE CARTRIDGE AND INFUSION SET AND THAT EVENING THE PATIENT'S BG WAS AROUND 300MG/DL. HE REMOVED THE SET AND NOTED THAT THE CANNULA WAS NOT BENT. HE REPLACED THE SET (BUT NOT THE CARTRIDGE) AND GAVE THE PATIENT AN INJECTION OF INSULIN. ON THE MORNING OF (B)(6) 2011 THE PATIENT'S BG WAS AROUND 400MG/DL; HE WAS GIVEN AN INJECTION OF INSULIN AND HIS BG CAME DOWN TO 180MG/DL. LATER IN THE MORNING THE BG ROSE AGAIN TO 504MG/DL WITH NAUSEA AND EMESIS, AT WHICH POINT THE FAMILY MEMBER TRANSPORTED HIM TO THE HOSPITAL. THE INFUSION SET WAS REMOVED AT THE HOSPITAL AND WAS NOT BENT OR KINKED. A FAMILY MEMBER SAID THAT THE PATIENT RECEIVED INTRAVENOUS FLUIDS AND INSULIN; HE CONTINUED TO WEAR THE PUMP DURING HOSPITALIZATION. THE FAMILY MEMBER CONFIRMED THAT HE CHANGED THE CARTRIDGE AND INFUSION SET DURING THE HOSPITALIZATION. HE SAID THAT WHEN HE REMOVED THE CARTRIDGE FROM THE PUMP, THE DISPLAY OF INSULIN REMAINING WAS AROUND 45 UNITS BUT THERE WAS VERY LITTLE INSULIN IN IT. HE REPORTED THAT THE CARTRIDGE COMPARTMENT APPEARED TO BE DRY BUT HAD A VERY STRONG ODOR OF INSULIN. HE IDENTIFIED THAT ONE OF THE TWO BLACK O-RINGS ON THE CARTRIDGE WAS DEFORMED AND ALLEGED THAT THE DEFECT CAUSED INSULIN TO LEAK OUT OF THE CARTRIDGE. THE FAMILY MEMBER STATED THAT NO DEFECT WAS OBSERVED IN THE CARTRIDGE WHEN HE FILLED IT ON (B)(6) 2011. WHEN QUESTIONED HE WAS UNABLE TO CONFIRM IF THE PLUNGER WAS OUT-OF-ALIGNMENT OR IF THE PLUNGER WAS ACCIDENTALLY PULLED OUT DURING THE FILLING PROCESS. THE FATHER REPORTED THAT THE PATIENT DID NOT DISCONTINUE INSULIN PUMP THERAPY AT ANY TIME; HE HAS NOT HAD ANY FURTHER ISSUES WITH BG EXCURSIONS OR WITH PRODUCT MALFUNCTIONS. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION THAT THE CARTRIDGE O-RINGS BECAME DEFECTIVE DURING USE AND THAT THE DEFECT CAUSED INSULIN TO LEAK OUT OF THE CARTRIDGE. THE PATIENT WAS SAID TO HAVE SUFFERED HYPERGLYCEMIA AS THE RESULT OF THE INSULIN LEAKAGE.

    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 B201453

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization