BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3923629 · Received July 9, 2014

    Report

    Report Number
    1823260-2014-05061
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 4, 2014
    Report Date
    March 23, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALLEGES THAT THE INFUSION DEVICE WAS DELIVERING TOO LOW AN AMOUNT OF INSULIN. THE PATIENT STATED THAT HER BLOOD GLUCOSE LEVEL HAD BEEN ELEVATED AS HIGH AS 28 MMOL/L. SHE SWITCHED TO HER BACKUP INFUSION DEVICE AND HER BLOOD GLUCOSE LEVELS RETURNED TO NORMAL. SHE THEN SWITCHED BACK TO HER PRIMARY DEVICE, BUT USING THE ACCESSORIES THAT WERE ON HER BACKUP DEVICE, AND HER BLOOD GLUCOSE LEVELS BECAME ELEVATED AGAIN. THE PATIENT SWITCHED BACK TO HER BACKUP DEVICE AND HER BLOOD GLUCOSE LEVELS RETURNED TO NORMAL. WHEN CHECKING THE HISTORY IN HER PRIMARY DEVICE, SHE STATED THERE WAS A BOLUS OF 1 UNIT OF INSULIN WHEN SHE HAD PROGRAMMED A BOLUS OF 5 UNITS OF INSULIN. WHILE DISCONNECTED FROM THE DEVICE, THE PATIENT BOLUSED 2 UNITS OF INSULIN AND DID NOT SEE ANY INSULIN FLOWING FROM THE END OF THE INFUSION TUBING. NO ADVERSE EVENT WAS REPORTED. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399617 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 HUMALOG