BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2871439 · Received December 5, 2012

    Report

    Report Number
    2183996-2012-01913
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 13, 2012
    Report Date
    March 12, 2013
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED ON (B)(4) 2013. THE INFUSION DEVICE WAS THOROUGHLY EVALUATED AND MEETS SPECIFICATIONS. THE DEVICE DELIVERS THE PROGRAMMED AMOUNT OF INSULIN CORRECTLY AND FUNCTIONS AS INTENDED. THE ISSUE REPORTED BY THE PATIENT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT'S DAUGHTER REPORTED THAT THE PT WAS HAVING CONCERNS WITH ELEVATED BLOOD GLUCOSE LEVELS FOR THE PAST TWO DAYS AS HIGH AS 380 MG/DL. THE PT FELT EXTREMELY TIRED AND SHE ATTEMPTED TO BOLUS TO CORRECT HER BLOOD GLUCOSE LEVEL. SHE ALSO GAVE HERSELF AN INJECTION OF 4.0 UNITS OF INSULIN. HER TARGET BLOOD GLUCOSE RANGE IS 80-120 MG/DL. SHE STATED THAT HER DOCTOR WAS NOT ABLE TO PRIME INSULIN THROUGH THE INFUSION TUBING ON HER PRIMARY INFUSION DEVICE. SHE SWITCHED TO HER BACKUP INFUSION DEVICE AND WAS ABLE TO PRIME USING THE SAME INFUSION TUBING. F/U WITH THE PT REVEALED THAT HER BLOOD GLUCOSE LEVEL WAS 130 MG/DL WHILE SHE WAS STILL USING THE BACKUP DEVICE. THE PT SWITCHED BACK TO HER PRIMARY DEVICE USING THE SAME ACCESSORIES SHE HAD BEEN USING ON HER BACKUP DEVICE AND HER BLOOD GLUCOSE LEVEL ELEVATED TO 250 MG/DL ON (B)(6) 2012 IN THE MORNING. LATER THAT DAY THE PT PASSED OUT AND WAS TAKEN TO THE HOSPITAL. SHE WAS ADMITTED TO THE HOSPITAL WITH A BLOOD GLUCOSE LEVEL OF 402 MG/DL. THE PT'S DAUGHTER DOES NOT KNOW WHAT ALL TYPES OF TREATMENT WERE PROVIDED AT THE HOSPITAL, BUT IV BAGS OF ANTIBIOTICS WERE GIVEN. THE PT WAS DIAGNOSED WITH A BLADDER INFECTION AND CONGESTIVE HEART FAILURE. SHE WAS ALSO DEHYDRATED AND HAD ISSUES WITH HER KIDNEYS. THE PT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2012. THE DOCTOR CHANGED SOME OF THE PT'S MEDICATIONS. NEITHER THE PT NOR HER DAUGHTER MADE ANY ALLEGATIONS THAT THE PERFORMANCE OF THE INFUSION DEVICE CONTRIBUTED TO THE HOSPITALIZATION. 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 LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP