BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3022643 · Received March 27, 2013

    Report

    Report Number
    2531779-2013-03115
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K048273
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT'S HUSBAND, A POOR HISTORIAN, MENTIONED DURING THE COURSE OF A CALL FOR ANOTHER ISSUE THAT THE PATIENT NEVER KNEW WHEN HER BLOOD GLUCOSE (BG) SHE WAS HIGH OR LOW AND HER BG WAS EASIER TO CONTROL ON INJECTION. BG EXCURSIONS RANGED FROM 27MG/DL TO HI ON THE METER. HUSBAND RECALLS A TIME WHEN BG WENT TO 33 MG/DL AND THEY HAD TO CALL EMS. ALSO SHE WOULD GO TO BED AND WAKE UP DURING THE NIGHT AND BG WOULD BE IN THE 20'S MG/DL REPORTS NO REASON FOR THE LOWS. REPORTEDLY HE GAVE GLUCAGON OFTEN AND HIS WIFE WENT ON DISABILITY DUE TO ABOUT 3 YEARS AGO. SHE ONCE PASSED OUT WITH LOW BG ON BUS GOING TO WORK FOR LOW BG. THEY DID NOT FEEL ERRATIC BG LEVELS WERE DUE TO PUMP UNDER OR OVER DELIVERING: HE STATES SHE WAS ON 3 DIFFERENT PUMPS AND SAME OCCURRED WITH ALL PUMPS. SHE COULD NOT DETECT HER BG FLUCTUATIONS. THE DOCTOR WOULD PROGRAM AND ADJUST RATES AND SAME ISSUES WOULD OCCUR, SHE WOULD HAVE LOW AND HIGH BG. REPORTS SHE WAS HOSPITALIZED MULTIPLE TIMES HE CAN'T REMEMBER SPECIFIC DETAILS OF THESE, ALSO SHE HAD PARKINSON'S DISEASE AND SUFFERED FROM INCONTINENCE WHEN HOSPITALIZED. THE PUMP WAS REMOVED BETWEEN (B)(6) 2012 AND (B)(6) 2012. THE HUSBAND FEELS ALL ISSUES WERE DUE TO BG MANAGEMENT AS PT COULD NOT BE REGULATED ON PUMP AND HAD DIFFICULTY REGULATING BG OFF THE PUMP- BUT DID BETTER ON INJECTION WHEN REMOVED FROM PUMP. HUSBAND DOES NOT HAVE PUMP AND HE DECLINES REVIEW OF PUMP HE IS NOT IMPLICATING PUMP DELIVERY. HE DECLINES RETURN OF PUMP. HE DECLINES ANY FURTHER TROUBLESHOOTING AND IS A POOR HISTORIAN ON ANY SEQUENCE OF EVENTS OTHER THAN BEING ABLE TO RECALL BG HIGHS AND LOWS. THERE IS NO ALLEGATION OF PUMP MALFUNCTION. THIS ISSUE IS BEING REPORTED DUE TO THE ALLEGATION THAT A PATIENT ON PUMP THERAPY WAS HOSPITALIZED FOR UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125400 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization