BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2982058 · Received February 8, 2013

    Report

    Report Number
    2183996-2013-00193
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 29, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. THE PUMP COMPONENTS ARE MECHANICALLY DAMAGED DUE TO A HARD MECHANICAL IMPACT. E8 POWER INTERRUPT ERRORS WERE FOUND IN THE HISTORY. THE INSULIN PUMP CORRECTLY TRIGGERED THESE DUE TO SEVERE DAMAGE TO THE ELECTRONIC COMPONENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT AFTER CHANGING THE INSULIN CARTRIDGE IN THE INFUSION DEVICE, THE DEVICE WOULD SHUT DOWN WITHIN A MATTER OF HOURS OR DAYS. THE DEVICE DID NOT PROVIDE AN ALARM BEFORE IT SHUT DOWN. THE PT HAS BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS AS HIGH AS 12 MMOL/L (216 MG/DL). HE HAS CORRECTED THE ELEVATED BLOOD GLUCOSE LEVELS VIA INJECTION OF INSULIN. THE PT NO LONGER HAS CONFIDENCE IN THE INFUSION DEVICE. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55346 ACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS INC. 00700006863 NA

    Patients

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