BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2871438 · Received December 5, 2012

    Report

    Report Number
    2183996-2012-01915
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 25, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT'S HUSBAND REPORTED THAT HIS WIFE HAD BEEN HOSPITALIZED ON (B)(6) 2012, DUE TO HYPERGLYCEMIA. HER BLOOD GLUCOSE MONITOR READ HI. SHE WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2012. ON (B)(6) 2012, THE PT'S HOME NURSE CHECKED THE PT'S BLOOD GLUCOSE LEVEL AND IT WAS 587 MG/DL. THE HOME NURSE RECOMMENDED THAT THE PT BE TAKEN TO THE ER AND THE PT'S HUSBAND DROVE HER TO THE HOSPITAL. THE PT WAS NOT FEELING SYMPTOMS OF ELEVATED BLOOD GLUCOSE LEVELS, BUT SHE FOLLOWED HER NURSE'S RECOMMENDATION TO GO TO THE HOSPITAL. THE PT WOULD NOT HAVE BEEN ABLE TO DRIVE TO THE HOSPITAL BECAUSE SHE LOST HER VISION A MONTH AGO. AT THE HOSPITAL, THE PT'S BLOOD GLUCOSE LEVEL WAS 393 MG/DL. HER BLOOD GLUCOSE LEVEL WAS CHECKED AGAIN AND IT WAS 500 MG/DL AND SHE WAS ADMITTED TO THE HOSPITAL FOR TREATMENT. SHE HAS HAD BLOOD GLUCOSE LEVELS IN THE 500'S FOR THE PAST TWO WEEKS. SHE HAS HAD TO UTILIZE INJECTIONS OF INSULIN IN ADDITION TO USING THE INFUSION DEVICE. THE PT WAS TREATED WITH LANTUS AND NOVALOG AT THE HOSPITAL. WHEN SHE WAS RELEASED FROM THE HOSPITAL HER BLOOD GLUCOSE LEVEL WAS 162 MG/DL. THE HOSPITAL ADVISED HER TO UTILIZE INJECTIONS OF INSULIN INSTEAD OF THE INFUSION DEVICE. THE PT WAS INTENDING TO GO BACK ON THE INFUSION DEVICE. HER HUSBAND STATED THAT THE INFUSION TUBING WOULD SOMETIMES GET CAUGHT ON SOMETHING AND DISCONNECT FROM THE INFUSION SITE AND WHEN SHE WOULD REATTACH THE INFUSION TUBING SHE WOULD NOT PRIME FIRST. THE PT'S HUSBAND STATED THAT THE DEVICE DISPLAYED THAT THERE WAS AN OCCLUSION ERROR THE PREVIOUS WEEK, BUT HE WAS ABLE TO CHANGE THE ACCESSORIES AND CLEAR THE ERROR MESSAGE. THE PT UTILIZES A COMPETITOR'S INFUSION SET. THE PT SOMETIMES FORGETS TO BOLUS AFTER A MEAL. THE PT'S HUSBAND IS UNSURE IF THE INFUSION DEVICE CONTRIBUTED TO THE ELEVATED BLOOD GLUCOSE LEVELS. THE PT MAY HAVE A COLD AND HAS BEEN EXPERIENCING ADD'L LEVELS OF STRESS. F/U WITH THE PT REVEALED THAT SHE DOES NOT MAKE ANY ALLEGATIONS ABOUT THE PERFORMANCE OF HER INFUSION DEVICE AND ITS ABILITY TO CORRECTLY DELIVER INSULIN. INFUSION DEVICE WAS REPLACED AND WAS REQUESTED TO BE RETURNED FOR PRODUCT EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP