BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3821924 · Received May 20, 2014

    Report

    Report Number
    1823260-2014-03576
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 8, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Description of Event or Problem · 1

    PATIENT STATED TWO WEEKS AGO THE METER AND PUMP WERE NOT COMMUNICATION SO HE WAS NOT GETTING HIS BOLUSES DELIVERED. PATIENT REPORTED AS A RESULT HE HAD AN EPISODE OF ELEVATED BLOOD GLUCOSE READINGS AND WAS ADMITTED TO THE HOSPITAL. PATIENT STATED HE TESTED HIS BLOOD GLUCOSE LEVEL AND IT WAS IN THE 400'S MG/DL. PATIENT REPORTED HE WAS TRYING TO GIVE HIMSELF INSULIN THROUGH THE PUMP BUT THE METER AND PUMP WERE NOT COMMUNICATING SO HE WAS NOT RECEIVING THE BOLUS. PATIENT STATED HE EVENTUALLY BECAME UNRESPONSIVE AND WAS LYING ON THE FLOOR; DID NOT PASS OUT. PATIENT REPORTED HIS DAUGHTER CALLED THE PARAMEDICS AND THEY TOOK HIM TO THE HOSPITAL WHERE THEY ADMINISTERED INSULIN THROUGH IV UNTIL HIS BLOOD GLUCOSE LEVEL CAME DOWN; COULD NOT SELF-TREAT. PATIENT STATED HIS BLOOD GLUCOSE LEVEL RETURNED TO NORMAL LATER THAT SAME DAY AND HE WAS DISCHARGED. PRODUCT WAS REPLACED AND REQUESTED TO RETURN THE ALLEGED PUMP FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300126 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR Hospitalization| R GABAPENTIN| DEXCOM CONTINUOUS BLOOD GLUCOSE MONITOR| DILTIAZEM| HUMALOG| VITAMIN B12| MULTIVITAMIN