BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1962728 · Received January 11, 2011

    Report

    Report Number
    2531779-2011-00180
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    September 26, 2009
    Report Date
    November 16, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE HOSP DISCHARGE SUMMARY ON (B)(6) 2009, THE PT WAS ADMITTED WITH COMA, RESPIRATORY FAILURE, HYPOGLYCEMIA, AND QUESTIONABLE SUSPECTED SUICIDE ATTEMPT. IT WAS NOTED THAT THE PT HAD A HISTORY OF SUICIDE ATTEMPTS, OVER DOSING, AND HYPOGLYCEMIA. IT WAS REPORTED THAT THE PT ADMINISTERED NARCOTICS AND BENZODIAZEPINES AS WELL AS INCREASED HIS INSULIN DELIVERY PRIOR TO THE HOSPITALIZATION. THE PUMP WAS NOT RETURNED TO ANIMAS AT THE TIME OF HOSPITALIZATION. THE PT CONTINUED TO WEAR THE PUMP UNTIL IT WAS RETURNED FOR AN UNRELATED ISSUE 6 MONTHS LATER. AT THAT TIME, THE AUDIO BOLUS BUTTON WAS FOUND TO BE UNRESPONSIVE AND THERE WAS CONTAMINATION UNDER THE KEY. THE PUMP HISTORY REVEALED THAT ALL BOLUSES WERE DELIVERED AS NORMAL BOLUSES; MOST OFTEN THE PT DID NOT ACCESS THE PUMP'S BOLUS CALCULATOR. THE PUMP SETTINGS INDICATED THAT THE AUDIO BOLUS FEATURE WAS TURNED OFF INDICATING THAT THE PT USED THE AUDIO BOLUS BUTTON TO ACCESS THE NORMAL BOLUS MENU. THERE WERE NO OTHER MALFUNCTIONS OR DEFECTS DISCOVERED. THE PUMP HISTORY DID NOT CONTAIN ANY DATA FROM THE TIME OF THE HOSPITALIZATION.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED AS A SEQUENCE OF EVENTS THAT BEGAN IN ON (B)(6) 2009. ON (B)(6) 2009, THE PT AND HIS GIRLFRIEND REPORTED ELEVATED BLOOD GLUCOSE AND ALLEGED THAT THE PUMP DID NOT DELIVER ADEQUATE INSULIN. THEY REVIEWED THE PUMP AT THAT TIME AND DISCOVERED THAT THE MONTH WAS PROGRAMMED INCORRECTLY; NO OTHER ERRORS OR MALFUNCTIONS WERE DETECTED DURING THIS CONTACT. THEY NOTED THAT ALL BOLUSES WERE APPROPRIATELY DELIVERED AND THE TOTAL DAILY DOSE APPEARED TO BE CONSISTENT AND ACCURATE. AN ANIMAS REP RECOMMENDED THAT HE REPLACE HIS INFUSION SET AND CONTACT HIS PHYSICIAN FOR FURTHER ADVICE. AT THE SAME TIME, IT WAS ALSO REPORTED THAT THE PT WAS HOSPITALIZED FOR HYPOGLYCEMIA ON (B)(6) 2009. THEY ALLEGED THAT THE PT RECEIVED TOO MUCH INSULIN; THERE WAS NO SUGGESTION ABOUT HOW THE INSULIN WAS ADMINISTERED. HIS BLOOD GLUCOSE FELL TO 12 MG/DL PER EMERGENCY MEDICAL PERSONNEL. IT WAS REPORTED THAT HE WAS IN A COMA DURING PART OF HIS HOSPITALIZATION. HE WAS DISCHARGED ON INSULIN PUMP THERAPY AND REMAINED ON THE SAME PUMP WITHOUT ANY FURTHER REPORTS OF HYPOGLYCEMIC EVENTS. THEY DECLINED OFFERS FROM ANIMAS REP'S FOR FURTHER TROUBLESHOOTING. SIX MONTHS LATER, THE PT REPORTED THAT THE AUDIO BOLUS BUTTON WAS INTERMITTENTLY RESPONSIVE. HE STATED THAT THE ISSUE BEGAN ABOUT TWO WEEKS EARLIER AND BECAME PROGRESSIVELY WORSE. THE PT NOTED THAT HE USED THIS BUTTON AS A SHORTCUT TO REACH THE NORMAL BOLUS SCREEN AND WAS STILL ABLE TO USE THE PUMP AT THE TIME OF THIS CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR1250

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization