BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2061197 · Received April 4, 2011

    Report

    Report Number
    2531779-2011-02091
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. THE EVALUATION OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT CONTACTED ANIMAS AND REPORTED ELEVATED BLOOD GLUCOSE (BG) LEVELS. THE PATIENT ALSO CALLED FOR A PUMP REPLACEMENT PER HER DOCTOR'S REQUEST. THE PATIENT INDICATED THAT FOR THE PREVIOUS 3 MONTHS, HER BG LEVELS HAD BEEN ERRATIC. IN SOME CASES, THE PATIENT CLAIMED THAT DEVELOPED KETONES AND SYMPTOMS OF FREQUENT URINATION AND THIRST WHEN HER BG LEVELS WERE ELEVATED. THE PATIENT CLAIMED THAT HER BG LEVELS WOULD RESPOND TO CORRECTIONS VIA INJECTIONS. SHE CLAIMED, HOWEVER, THAT HER BG LEVELS WOULD REMAIN ELEVATED WHEN BOLUSING VIA THE PUMP. NO ISSUES WERE NOTED WITH THE INFUSION SET OR CANNULA(S) AT THE TIME OF ANY BG ELEVATIONS. SHE DENIED THAT THE CANNULAS WERE BENT OR KINKED. SHE ALSO DENIED THAT THERE WERE ANY ISSUES WITH THE CARTRIDGES OR INFUSION SETS. THE PATIENT'S INSULIN WAS NOT DISCOLORED, CLOUDY, OR EXPIRED. THE PUMP'S ALARM HISTORY WAS NEGATIVE. THE ANIMAS REPRESENTATIVE INVOLVED IN THIS CONTACT INFORMED THE PATIENT THAT THERE WAS NO EVIDENCE TO INDICATE A PUMP MALFUNCTION. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPERGLYCEMIA. SHE ALSO ALLEGED THAT HER ELEVATED BG LEVELS WERE NOT RESPONDING TO BOLUSES ADMINISTERED VIA THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening