BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3061792 · Received April 16, 2013

    Report

    Report Number
    2183996-2013-00676
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    April 7, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. THE PRODUCTION DATA OF THE INSULIN PUMP COMPLIES WITH THE SPECIFICATIONS. THE PRODUCTION REPORTS WERE REVIEWED. THE LOT NUMBER OF THE INFUSION SET AND CARTRIDGE IS UNKNOWN; THEREFORE, NO INVESTIGATION COULD BE PERFORMED. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A CERTIFIED DIABETES EDUCATOR REPORTED PATIENT WAS HOSPITALIZED WITH DIABETIC KETOACIDOSIS. SHE WOKE ON (B)(6) 2013 WITH HYPERGLYCEMIA IN THE 400 MG/DL RANGE. SHE CHANGED THE INFUSION SET AND FORGOT TO PRIME THE TUBE. SHE COMPLETED THE PRIME AND THEN DELIVERED INSULIN VIA INFUSION DEVICE AND PEN, BUT THIS DID NOT LOWER HER BLOOD GLUCOSE. SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013 AND TREATED WITH SUBCUTANEOUS INSULIN, AND HER BLOOD GLUCOSE HAD RETURNED TO NORMAL AT THE TIME OF THE REPORT. NO FURTHER ISSUES WERE NOTED DURING TROUBLESHOOTING. CDE REPORTED THE PATIENT HAS LOST CONFIDENCE AND THE PHYSICIAN BELIEVES "THERE MUST BE SOMETHING WRONG" WITH THE INFUSION DEVICE. CDE REQUESTED ADDITIONAL TRAINING FOR THE PATIENT, INCLUDING SICK-DAY MANAGEMENT AND HOW AND WHEN TO TEST FOR KETONES. THE INFUSION DEVICE, ADAPTER, CARTRIDGE, AND INFUSION SET WERE REPLACED AND REQUESTED FOR EVALUATION. FOLLOW-UP WAS COMPLETED WITH THE PATIENT ON (B)(6) 2013. SHE WAS RELEASED FROM THE HOSPITAL THAT DAY AND WAS FEELING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163503 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 044 YR Hospitalization| R NOVOLOG