BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3443363 · Received November 1, 2013

    Report

    Report Number
    2531779-2013-19380
    Event Type
    Injury
    Date Received
    November 1, 2013
    Report Date
    October 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/19/2014 WITH THE FOLLOWING FINDINGS:. TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. THE BLACK BOX CONTAINS DATES FROM (B)(6) 2013 TO (B)(6) 2013. THE SCRIPTS STATES ¿HOSPITALIZATION OVER 1 YR AGO, NOT ALL INFORMATION AVAILABLE.¿ THE BLACK BOX AND HISTORY OF THE PUMP FOR 1 YR AGO ARE NOT AVAILABLE DUE TO CONTAINED USE OF THE PUMP. REVIEW OF THE AVAILABLE BLACK BOX AND ALARM HISTORY SHOW NO ERRORS OR ALARMS RELATED TO THE COMPLAINT. THE DAILY INSULIN DELIVERY TOTALS WERE FOUND TO CORRECTLY REFLECT THE USER'S PROGRAMMED BASAL RATES. A DELIVERY ACCURACY TEST WAS PERFORMED; PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. UNRELATED TO THE COMPLAINT,N THE DISPLAY SCREEN HAS A PINKISH CONTRAST; THE SCREEN IS STILL ABLE TO BE SAFELY READ. THE KEYPAD IS TORN AT THE OK KEY. THE CONTRAST, UP, DOWN AND OK KEYS ARE FULLY RESPONSIVE TO USER PRESSES. REMOVED THE KEYPAD COVER; CONTAMINATION WAS FOUND UNDER THE CONTRAST, UP AND DOWN KEY CONTACTS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING A HOSPITALIZATION THAT OCCURRED ONE YEAR EARLIER FOR DIABETIC KETOACIDOSIS, PNEUMONIA, SHINGLES, AND HEART ATTACK. THE REPORTER INDICATED HAVING ELEVATED BLOOD GLUCOSE LEVELS WITH VOMITING EARLIER IN THE DAY. THE REPORTER STATED THAT BLOOD GLUCOSE LEVELS ELEVATED AS HIGH AS 700 MG/DL IN THE HOSPITAL AND WAS ADMITTED WITH DIABETIC KETOACIDOSIS, PNEUMONIA, SHINGLES AND A HEART ATTACK. THE REPORTER INDICATED GOING OFF THE PUMP FOR A PERIOD OF TIME AFTER THE HOSPITALIZATION BUT HAS SINCE RESUMED THE PUMP WITHOUT FURTHER ISSUES. THE REPORTER CONFIRMED THAT THE EVENT WAS NOT BEING ATTRIBUTED TO THE PUMP. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS AND THE USE OF THE PUMP COULD NOT BE RULED OUT AS A POSSIBLE CONTRIBUTOR TO THE PATIENT¿S EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562869 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization