BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1855176 · Received September 30, 2010

    Report

    Report Number
    2183996-2010-01969
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 13, 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
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED HAVING TO GO TO THE HOSPITAL DUE TO RENAL FAILURE. PT STATED SHE BEGAN HAVING ELEVATED BLOOD GLUCOSE ISSUES WHEN SHE HAD 2 FAMILY MEMBERS PASS AWAY ONLY A FEW WEEKS APART. PT REPORTED HER BLOOD GLUCOSE READINGS "SKYROCKETED" DUE TO THE STRESS. PT WAS UNABLE TO RECALL THE EXACT READINGS. PT STATED SHE WAS GIVEN A FORMULA BY HER "FOOD COACH" ON HOW TO CALCULATE HOW MUCH INSULIN SHE NEEDED TO TAKE AT A GIVEN TIME. PT REPORTED THE ADVICE DID NOT HELP HER BLOOD GLUCOSE BECAUSE SHE CONTINUED TO RECEIVE ELEVATED READINGS. PT STATED SHE ATTEMPTED TO FOLLOW THE ADVICE FOR ABOUT 6 WEEKS AND DURING THAT TIME SHE RECEIVED READINGS IN THE HIGH 200'S MG/DL. PT REPORTED SHE STATED TO HAVE SYMPTOMS OF BLURRY VISION AND WAS TIRED MOST OF THE TIME. PT STATED HER A1C WAS 9.2% AFTER USING THE FORMULA, BUT WAS 6.2% ABOUT 6 WEEKS PRIOR TO USING THE FORMULA. PT REPORTED SHE DECIDED TO USE HER OWN METHOD OF CALCULATING HOW MUCH INSULIN SHE SHOULD TAKE BY ADJUSTING THE AMOUNT OF INSULIN TO MATCH THE FOOD SHE ATE . PT STATED SHE HAD AN INFECTION AND BEGAN TO HAVE ISSUES WITH HER KIDNEYS, BLADDER, AND LUNGS. PT REPORTED SHE COULD NOT RECALL THE MORNING OF THE HOSPITAL EPISODE, BUT HER HUSBAND TOLD HER THAT SHE MENTIONED HER LEGS FELT HEAVY AND SHE HAD A LOT OF TROUBLE BREATHING. PT STATED SHE WAS INCOHERENT, HAD A FEVER OF 105, AND WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010 AND RELEASED ON (B)(6) 2010. PT REPORTED HER BLOOD GLUCOSE WAS 59 MG/DL THIS MORNING AT 3 AM; SHE FELT IT WAS A LITTLE LOW SO SHE ATE, AND THEN WENT BACK TO SLEEP. PT STATED SHE TESTED LATER IN THE MORNING AND HAD A BLOOD GLUCOSE READING OF 150 MG/DL WHICH IS IN THE TARGET RANGE. PT REPORTED HER INFUSION DEVICE DID NOT DISPLAY ANY ERROR OR ALERT MESSAGES AND SHE HAD BEEN EXPERIENCING THE ELEVATED READINGS FOR THE PAST 6 WEEKS. PT STATED SHE FILLS THE INSULIN CARTRIDGES AFTER THE INSULIN IS REMOVED FROM THE REFRIGERATOR. ADVISED TO ALWAYS ALLOW THE INSULIN TO WARM TO ROOM TEMPERATURE IF POSSIBLE. PT REPORTED SHE ALSO NEEDED TO ADJUST HER MEDICATION FOR ANOTHER MEDICAL CONDITION. PT STATED SHE HAS ISSUES REMOVING HER BATTERY COVER AT TIMES. SENT BATTERY COVER; 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 51 YR Hospitalization| O| R INSULIN, (DATE OF TX: (B)(6) - (B)(6))| (B)(6))| INSULIN INFUSION SET, (DATE OF TX: (B)(6) -