BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3623993 · Received February 12, 2014

    Report

    Report Number
    1823260-2014-00925
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 18, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Description of Event or Problem · 1

    PATIENT REPORTED SHE HAS BEEN EXPERIENCING UNEXPLAINED ELEVATED BLOOD GLUCOSE LEVEL FOR THE LAST 3 DAYS. PATIENT STATED HER BLOOD GLUCOSE READINGS HAVE RANGED FROM 160-247 MG/DL. PATIENT'S TARGET BLOOD GLUCOSE RANGE IS 90-150 MG/DL. PATIENT REPORTED SHE CALLED HER DOCTOR AND THE DOCTOR ADVISED HER TO INCREASE HER BOLUS AMOUNTS BY 25-50% DEPENDING ON THE READING. PATIENT STATED THE ELEVATED READINGS ARE OCCURRING AT DIFFERENT TIMES OF THE DAY. PATIENT REPORTED SHE WENT TO URGENT CARE TO SEE IF SHE HAS SOME KIND OF INFECTION; SHE DOES NOT. ADVISED TO SWITCH TO BACKUP INFUSION DEVICE WITH THE SAME ACCESSORIES. ON FOLLOW CALL ON (B)(6) 2014 PATIENT REPORTED SHE WENT ON THE BACKUP INFUSION DEVICE AND ALMOST IMMEDIATELY HER READINGS LOWERED INTO TARGET RANGE. THE PATIENT DID NOT REPORT NEEDING ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92092 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR HUMALOG| SYNTHROID| PROTONIX| CRESTOR| ELMIRON| DILTAZAM| PLAVIX| ASPIRIN LOW DOSE