BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3243605 · Received July 23, 2013

    Report

    Report Number
    2183996-2013-01368
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    July 11, 2013
    Report Date
    July 31, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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.

    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.

    Description of Event or Problem · 1

    ON (B)(4) 2013, IT WAS REPORTED THAT ON (B)(6) 2013 AT 9:20 PM, THE PATIENT'S WIFE FOUND HIM UNCONSCIOUS. HIS BLOOD GLUCOSE LEVEL WAS 37 MG/DL. SHE GAVE HIM A SODA AND AN INJECTION OF GLUCAGON. SHE CALLED FOR AN AMBULANCE. AT 9:40 PM, HIS BLOOD GLUCOSE LEVEL WAS 38 MG/DL WHEN THE EMERGENCY DOCTOR MEASURED IT. HE WAS TREATED WITH AN IV OF GLUCOSE AND TEN MINUTES LATER HIS BLOOD GLUCOSE LEVEL WAS 98 MG/DL. THE PATIENT WAS STILL DISORIENTED. THEY DROVE HIM TO THE HOSPITAL WHERE HE WAS ADMITTED TO THE INTENSIVE CARE UNIT. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343133 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS INC 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR Hospitalization| R SPIROMAKTON| HUMALOG| MAGNESIUM| EMERGU 1020| EUSATAN 80| FORIOSOMIT 40| METOPOROL| PANTOPRAZOL| ALLOPURINOL 300| DIGIMERK| ASS 100