BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3121572 · Received May 21, 2013

    Report

    Report Number
    2183996-2013-00889
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT FOR THE PAST 1-2 WEEKS, THE PATIENT'S BLOOD GLUCOSE LEVEL HAD OCCASIONALLY BEEN ELEVATED. THE PATIENT MADE CORRECTIONS TO THE ELEVATED LEVELS AFTER CHANGING THE INFUSION DEVICE'S ACCESSORIES. ON (B)(6) 2013 IN THE EVENING, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS HI AND HE WAS ABLE TO CORRECT THE LEVEL AFTER CHANGING THE ACCESSORIES. ON (B)(6) 2013 AT 7:00PM, HIS BLOOD GLUCOSE LEVEL WAS AGAIN HI, BUT HE WAS UNSUCCESSFUL CORRECTING THE LEVEL WITH THE INFUSION DEVICE EVEN AFTER CHANGING THE ACCESSORIES. THE PATIENT'S PARENTS TOOK HIM TO THE HOSPITAL AT 11:00PM WHERE HE RECEIVED AN IV OF INSULIN. THE PATIENT SWITCHED TO HIS BACKUP DEVICE AND HIS BLOOD GLUCOSE LEVELS RETURNED TO NORMAL. THE HOSPITAL THINKS HIS PRIMARY INFUSION DEVICE WAS NOT DELIVERING ENOUGH INSULIN. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224180 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 005 YR Hospitalization| R