BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 2970384 · Received February 20, 2013

    Report

    Report Number
    2183996-2013-00218
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    February 7, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    E,8 A2 AND NO E2 WERE FOUND IN THE HISTORY. THE ACID OF THE DOUBLE LAYER CAPACITOR (GOLDCAP) HAS LEAKED OUT AND THIS DEFECT CAUSES AN UNINTENDED SHUT DOWN OF THE INSULIN PUMP.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. IT WAS UNKNOWN IF THE PATIENT USED ANY CONCOMITANT MEDICAL PRODUCTS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THAT HIS INFUSION DEVICE ALERTED HIM THAT THE BATTERY WAS LOW. HE CHANGED TO A NEW BATTERY AND THE LOW BATTERY ALERT WAS AGAIN DISPLAYED. THE PATIENT CHANGED THE BATTERY AGAIN AND THEN THE DEVICE DISPLAYED "SW" AND ANOTHER WORD, BUT HE COULD NOT READ THE WORD BEFORE THE DEVICE SHUT DOWN. HE CHANGED THE BATTERY AGAIN, BUT THE LOW BATTERY ALERT DISPLAYED AGAIN. THE DEVICE HISTORY WAS CHECKED AND IT DID NOT SHOW THAT IT HAD EVER DISPLAYED E2 (BATTERY EMPTY) BEFORE THE DEVICE SHUT DOWN. THE PATIENT STATED THAT THE BATTERY CONTACTS WERE NOT BENT. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73354 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR