BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3831004 · Received May 23, 2014

    Report

    Report Number
    1823260-2014-03693
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 REPORTED EXPERIENCING A LOW BLOOD GLUCOSE INCIDENT THAT OCCURRED ON (B)(6) 2014. PATIENT STATED HE HAD AN EPILEPTIC SEIZURE AT 7 AM ON (B)(6) 2014 AND LAY DOWN ONTO THE FLOOR; DID NOT LOSE CONSCIOUSNESS. PATIENT REPORTED HIS SON-IN-LAW TESTED HIS BLOOD GLUCOSE LEVEL TWICE WITH 5 MINUTES WITH RESULTS OF LO AND 34 MG/DL. PATIENT STATED HIS SON- IN-LAW INJECTED HIM WITH GLUCAGON AND CALLED FOR PARAMEDICS. PATIENT REPORTED THE PARAMEDICS ARRIVED AND TOOK HIS BLOOD GLUCOSE LEVEL 3 TIMES ON THEIR METER WITH RESULTS OF LO, LO, AND 28 MG/DL; WAS GIVEN DEXTROSE AND TAKEN TO THE HOSPITAL. PATIENT STATED THE HOSPITAL TESTED HIS BLOOD GLUCOSE LEVEL 3 TIMES; RESULTS NOT PROVIDED. PATIENT REPORTED HE WAS NOT ADMITTED TO THE HOSPITAL BUT WAS TREATED WITH AN IV OF UNKNOWN CONTENT. PATIENT STATED PRIOR TO THE INCIDENT HIS MOST RECENT BOLUS WAS 0.6 UNITS AT 9:54 PM ON (B)(6) 2014. PATIENT BELIEVES THE INFUSION DEVICE DELIVERED TOO MUCH INSULIN CAUSING HIS LOW BLOOD GLUCOSE INCIDENT. PATIENT REPORTED RECEIVING AN ALARM FROM THE INFUSION DEVICE ABOUT 3 HOURS PRIOR TO THE LOW BLOOD GLUCOSE INCIDENT; NO ALARM FOUND IN THE DEVICE ALARM HISTORY. PATIENT NO LONGER HAS THE CARTRIDGE USED DURING THE INCIDENT. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE, INFUSION SET AND ADAPTER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307595 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR Hospitalization| R HUMALIN U100| CANE| MINOXIDIL| GLUCAGON| DIOVAN| BLOOD PRESSURE MACHINE| BLOOD SUGAR METER (VOCAL POINT)