BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1971434 · Received January 13, 2011

    Report

    Report Number
    2531779-2011-00285
    Event Type
    Injury
    Date Received
    January 13, 2011
    Report Date
    December 15, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE REPORTER (AN ANIMAS REP) CONTACTED ANIMAS ALLEGING MULTIPLE REPLACE BATTERY ALARMS WITH A PUMP AND ELEVATED BLOOD GLUCOSE WITH A PT. THE REPORTER INDICATED THAT A PT WAS ADMITTED TO A HOSPITAL FOR DKA ON (B)(6) 2010. AT THAT TIME THE PUMP WAS REPORTEDLY DISCONNECTED. THE REPORTER DID NOT HAVE ANY INFO REGARDING THE PT'S BLOOD GLUCOSE (BG) LEVEL UPON ADMISSION OR WHAT EVENTS LED UP TO THE ADMISSION. SHE ALSO DID NOT HAVE INFO REGARDING THE PT'S DISCHARGE FROM THE HOSPITAL ON (B)(6) 2010. AFTER THE ADMISSION, THE PT'S PARENTS REPORTEDLY ORDERED A NEW BATTERY CAP. ACCORDING TO THE REPORTER, THE PUMP WAS RESUMED ON (B)(6) 2010. THE REPORTER NOTED THAT THE PUMP "CONTINUED TO GIVE REPLACE BATTERY" AND THE BATTERY CAP DID NOT SEEM TO BE FITTING CORRECTLY. THE REPORTER DENIED THAT THE CASE WAS CRACKED AND INDICATED THAT THE BATTERY CAP WAS NEW. THE PUMP'S SETTINGS WERE REPORTEDLY CORRECT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER INDICATED THAT THE PT WAS HOSPITALIZED FOR DKA. HOWEVER, THERE IS INSUFFICIENT INFO AT THIS TIME TO DETERMINE IF THE PUMP CAUSED OR CONTRIBUTED TO THE PT'S INJURY.

    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 Hospitalization| L