BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3955073 · Received July 24, 2014

    Report

    Report Number
    1823260-2014-05491
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    PATIENT'S MOTHER REPORTED THAT WHILE PRIMING THE PUMP, SHE NOTICED THAT THE PUMP IS COUNTING DOWN THE INSULIN HOWEVER THE PISTON ROD WAS NOT MOVING. MOTHER STATED THIS WAS TESTED SEVERAL TIMES AND THE SAME THING OCCURRED EACH TIME. MOTHER REPORTED THE PATIENT IS CURRENTLY IN THE ACCIDENT AND EMERGENCY DEPT. IN THE HOSPITAL SHE WOKE UP TODAY WITH ELEVATED BLOOD GLUCOSE LEVELS AND KETONES. MOTHER STATED THE PATIENT EXPERIENCED AN E4 (OCCLUSION) ERROR THIS MORNING AND WHEN CHECKING HER BLOOD GLUCOSE LEVEL, SHE HAD A READING OF 23 MMOL/L AND 5.6 KETONES. MOTHER REPORTED THE PATIENT WAS VERY SICK, SO SHE TOOK HER TO THE HOSPITAL WHERE SHE HAS BEEN ON A DRIP FOR DEHYDRATION AND BEN GIVEN INSULIN VIA NOVORAPID PEN. MOTHER STATED OVER THE LAST 4 WEEKS, THE PATIENT HAS HAD A LOT OF E4 (OCCLUSION) ERRORS. MOTHER REPORTED THEY CHANGED THE CANNULA, TUBING AND CARTRIDGE EACH TIME. MOTHER STATED SHE EVEN CHANGES THE BATTERY AND ADAPTER AS WELL. PATIENT USES THE INSERTION DEVICE TO INSERT ALL CANNULAS. MOTHER REPORTED SHE HAD NOT NOTICED ANY DEFECTS WITH THE CANNULA AT ALL AND IT DOES NOT LOOK KINKED; NO SIGNS OF LEAKS EITHER. MOTHER STATED THE NURSE HAS LOOKED AT THE PATIENT'S INFUSION SITES WHICH ARE ALL FINE AS WELL. MOTHER REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL IS CURRENTLY 16 MMOL/L WITH 1.6 KETONES. MOTHER STATED THE HOSPITAL ADVISED THE PATIENT WILL BE ABLE TO LEAVE LATER TODAY AS SHE IS FEELING A LOT BETTER. REQUESTED RETURN OF THE ALLEGED PUMP FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434053 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 009 YR Hospitalization| R