BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1942529 · Received December 22, 2010

    Report

    Report Number
    2183996-2010-02684
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    October 1, 2010
    Report Date
    December 10, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD AND RESULTS: NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED HAVING ERRATIC BLOOD GLUCOSE SINCE (B)(6) 2010 WHICH RANGES FROM 40-240 MG/DL. PATIENT STATED SHE VISITED HER MEDICAL PROFESSIONAL TODAY AND HE ADJUSTED HER BASAL RATES. PATIENT REPORTED SHE HAS LOW BLOOD GLUCOSE EPISODES IN THE MORNING OR BEFORE LUNCH TIME AROUND 11:00 AM. PATIENT STATED HER BLOOD GLUCOSE TODAY WAS 40 MG/DL AND SHE WAS SEMI-CONSCIOUS. PATIENT REPORTED THE EMTS WERE CALLED DUE TO HER LOW BLOOD GLUCOSE LEVEL. PATIENT STATED THE EMTS PROVIDED AN INSULIN DRIP AND GLUCOSE. PATIENT REPORTED SHE DID NOT GO TO THE HOSPITAL BUT WAS NOT ABLE TO TREAT HERSELF WITHOUT ASSISTANCE DUE TO THE LOW BLOOD GLUCOSE LEVEL. PATIENT STATED THE EMTS LEFT WHEN HER BLOOD GLUCOSE WAS 236 MG/DL AND ADVISED HER TO VISIT A MEDICAL PROFESSIONAL. PATIENT REPORTED SHE PERFORMS A BOLUS AFTER EATING MEALS AND SHE CHANGES THE INSULIN CARTRIDGE EVERY 7 DAYS. PATIENT STATED SHE IS EXERCISING AND EATING LESS THAN NORMAL. PATIENT REPORTED SHE WOULD LIKE TO REMAIN ON THE INFUSION DEVICE WHILE USING THE NEW BASAL RATES FOR A FEW DAYS. PATIENT STATED IF SHE STILL NOTICES LOW BLOOD GLUCOSE ISSUES, SHE WOULD LIKE TO SWITCH TO THE BACKUP INFUSION DEVICE. SUBMITTED REQUEST FOR ADDITIONAL TRAINING. ON FOLLOW UP ON (B)(6) 2010, REGIONAL CLINICAL SPECIALIST REPORTED SPEAKING WITH THE PATIENT AND ADVISED HER TO DISCONNECT FROM HER INFUSION DEVICE AND BOLUS 2.0 UNITS OF INSULIN. REGIONAL CLINICAL SPECIALIST STATED SHE ADVISED PATIENT IF THE INSULIN MOVES OUT OF THE INFUSION TUBING, THEN AT HER NEXT INFUSION SITE CHANGE, TO MOVE TO A COMPLETELY NEW LOCATION. REGIONAL CLINICAL SPECIALIST REPORTED IF PATIENT CONTINUES TO EXPERIENCE ERRATIC BLOOD GLUCOSE LEVELS AFTER CHANGING TO THE NEW INFUSION SITE, SHE WILL BEGIN BASAL RATE TESTING OVERNIGHT AND THEN WILL TEST DURING THE A.M HOURS. ON (B)(6) 2010, CLINICAL SPECIALIST REPORTED PATIENT HAS AN APPOINTMENT WITH A TRAINER ON (B)(6) 2010. ON (B)(6) 2010, REGIONAL CLINICAL SPECIALIST REPORTED PATIENT HAS COMPLETED BASAL RATE TESTING AND HER NUMBERS ARE ALL WITHIN RANGE EXCEPT FOR THE MORNING FROM THE TIME SHE GETS UP UNTIL NOON. REGIONAL CLINICAL SPECIALIST STATED PATIENT IS GOING TO RETEST HER BASAL RATES DURING THE A.M HOURS AFTER CHECKING A 3:00 AM BASAL RATE; WILL ADJUST IF NECESSARY. REGIONAL CLINICAL SPECIALIST REPORTED PATIENT HAS BEEN USING BRAND NEW INFUSION SITES AND IS PLEASED HER BLOOD GLUCOSE IS BETTER CONTROLLED. NO PRODUCT RETURN WAS REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention INSULIN INFUSION SET| INSULIN