BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3052078 · Received April 11, 2013

    Report

    Report Number
    2183996-2013-00640
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO FDA. DEVICE WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATIONS, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. (B)(4): DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A COMPANY REPRESENTATIVE REPORTED THAT THE PATIENT HAD EXPERIENCED BLOOD GLUCOSE PROBLEMS WITHIN THE FIRST 24 HOURS OF USING HIS NEW INFUSION DEVICE. BEFORE SWITCHING TO INFUSION DEVICE THERAPY, HIS BLOOD GLUCOSE LEVELS FLUCTUATED FROM 20-400'S MG/DL. DURING THAT FIRST 24 HOURS, AT 5:30PM ON (B)(6) 2013, HIS BLOOD GLUCOSE LEVEL DROPPED TO 29 MG/DL AND AFTER DRINKING JUICE IT RETURNED TO NORMAL. THE PATIENT REQUIRED OUTSIDE ASSISTANCE RETRIEVING THE JUICE AND WOULD NOT HAVE BEEN ABLE TO SELF-TREAT THE LOW BLOOD GLUCOSE LEVEL. THE PATIENT'S NURSE NOTICED THE PATIENT NEEDED ASSISTANCE DUE TO A "BLANK STARE". TROUBLESHOOTING WITH THE PATIENT DID NOT REVEAL ANY PROBLEMS WITH THE PERFORMANCE OF THE INFUSION DEVICE. ADDITIONAL TRAINING HAS BEEN OFFERED TO THE PATIENT; THE PATIENT HAS DISCONTINUED USE OF THE DEVICE UNTIL ADDITIONAL TRAINING IS RECEIVED. NO PRODUCT WILL BE REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156863 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR Required Intervention NOVOLOG| LANTUS