BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHECK SPIRIT COMBO

    MDR report key: 2926244 · Received January 14, 2013

    Report

    Report Number
    2183996-2012-02145
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 23, 2012
    Report Date
    December 28, 2012
    Manufacturer
    ROCHE HEALTH SOLUTIONS
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, PATIENT REPORTED SHE HAS EXPERIENCED HYPOGLYCEMIA EACH NIGHT SINCE SHE STARTED A NEW INFUSION DEVICE 1 WEEK AGO, AND SHE IS CONCERNED THERE IS "SOMETHING WRONG." ON (B)(6) 2012 BETWEEN 4:00-8:00 A.M., PATIENT WAS AWAKENED BY PARAMEDICS WHILE LAYING IN BED. HER HUSBAND BECAME CONCERNED WHEN SHE DID NOT ANSWER HIS CALLS, AND HE CONTACTED THE PARAMEDIC. SHE DOES NOT KNOW WHAT HER BLOOD GLUCOSE WAS AND BELIEVES SHE WAS TREATED WITH A GLUCAGON INJECTION. SHE ALSO RECEIVED AN IV AND WAS NOT TRANSPORTED TO THE HOSPITAL. SHE TESTED HER BLOOD GLUCOSE BEFORE BED ON (B)(6) 2012 AND IT WAS "FINE." SHE CONFIRMED THE BASAL RATE PROGRAMMED ON HER CURRENT INFUSION DEVICE IS THE SAME AS HER PREVIOUS. SHE HAS NOT BLOUSED DURING THE DAY SINCE THE PARAMEDICS CAME ON (B)(6) 2012. HER EATING HABITS HAD CHANGED WITH THE HOLIDAYS, AND NO FURTHER ISSUES WERE NOTED DURING TROUBLESHOOTING. SHE REPORTED SHE WOULD SWITCH TO HER PREVIOUS INFUSION DEVICE AND CONTACT HER HEALTHCARE PROFESSIONAL TO SEE IF THE BASAL RATES NEED TO BE ADJUSTED. SHE STATED NO FOLLOW-UP CALL WAS NECESSARY. THREE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION, BUT THESE WERE NOT SUCCESSFUL. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20557 ACCU-CHECK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention INSULIN INFUSION PUMP| INSULIN| DATE OF THERAPY: UNK| RELATED ACCESSORIES