BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3103127 · Received May 9, 2013

    Report

    Report Number
    2183996-2013-00817
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 27, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. PRODUCTION DATA WAS REVIEWED AND COMPLY WITH SPECIFICATIONS. THE ISSUE REPORTED BY THE PATIENT COULD NOT BE DUPLICATED. NO PRODUCT WAS RETURNED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. NO PRODUCT HAS BEEN REQUESTED TO BE RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT'S WIFE REPORTED THAT HER HUSBAND WAS IN THE HOSPITAL WITH AN ELEVATED BLOOD GLUCOSE LEVEL OF 691 MG/DL. AT LUNCHTIME ON (B)(6) 2013 HIS BLOOD GLUCOSE LEVEL WAS 118 MG/DL. HIS NORMAL BLOOD GLUCOSE RANGE IS 100-140 MG/DL. AT 6:30PM HIS BLOOD GLUCOSE LEVEL AS OVER 400 MG/DL AND HE HAD NOT EATEN YET. THE PATIENT BOLUSED 24.6 UNITS OF INSULIN, BUT HE DOES NOT THINK IT WAS SUCCESSFUL. AT 11:30PM HIS BLOOD GLUCOSE LEVEL WAS HI AND HE GAVE HIMSELF AN INJECTION OF 15 UNITS OF INSULIN. THE PATIENT'S WIFE THEN DROVE HIM TO THE HOSPITAL. HE WAS GIVEN AND IV OF SALINE AND INSULIN. THE PATIENT FELT THIRSTY, BUT HAD NO OTHER SYMPTOMS OF HYPERGLYCEMIA. ON THE DATE OF THE EVENT THE PATIENT CHANGED THE INFUSION SET AT 6:30PM AND STATED THAT BLOOD CAME OUT WHEN HE REMOVED THE CANNULA. THE PATIENT THINKS THE INFUSION SET WAS THE CAUSE OF THE ELEVATED BLOOD GLUCOSE LEVELS. THE PATIENT USES A COMPETITOR'S INFUSION SET. FOLLOW-UP WITH THE PATIENT REVEALED THAT HIS DOCTOR WANTS HIM REMOVED FROM THE INFUSION DEVICE BECAUSE HE DOES NOT FEEL THAT HE IS A GOOD CANDIDATE FOR INFUSION DEVICE THERAPY. THE DOCTOR DID NOT MAKE ANY ALLEGATIONS AGAINST THE PERFORMANCE OF THE INFUSION DEVICE. THE INFUSION SET AND INSULIN CARTRIDGE HAD BEEN DISCARDED. THE INFUSION DEVICE WAS NOT REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204440 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR Hospitalization| R HUMALOG| CARVEDILOL| SPIRONOLACATONE| ENALAPRIL| L-THYROXINE| FUROSCMIDE| FISH OIL| ASPRIN| CLOPIDOGREL| METFORMIN| ARVOSTATIN