BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3242245 · Received July 23, 2013

    Report

    Report Number
    2183996-2013-01343
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 13, 2013
    Report Date
    February 21, 2014
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PATIENT STATED THAT THE PUMP HAD INTENTIONAL WATER CONTACT. THE PUMP IS NOT WATERPROOF FOR SWIMMING OR OTHER CONTACTS WITH WATER. THE BUTTONS AND DISPLAY MEET THE SPECIFICATION ACCORDING TO SHORT TEST. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    CONCLUSION - THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCTION DATA SHOWS NO DEVIATIONS OF THE SPECIFICATIONS RESULT AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. AS THE PRODUCT HAS NOT RETURNED FOR EVALUATION, THE COMPLAINT COULD NOT BE INVESTIGATED. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THAT THE DISPLAY ON HER INFUSION DEVICE WAS INCOMPLETE. SHE STATED THAT HER DEVICE HAD BEEN EXPOSED TO WATER AND HAD DISPLAYED E7 (ELECTRONIC ERROR). SHE STATED THAT HER DEVICE WAS EXPOSED TO DIRT AND SHE WANTED TO CLEAN IT OUT, SO SHE PLACED THE DEVICE IN WATER. SHE IS UNABLE TO READ THE DISPLAY ON THE DEVICE. THE DEVICE IS NOT RESPONDING TO THE CHECK BUTTON BEING PRESSED. 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
    342787 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 039 YR BALSARTAN| CRESTOR| SYNTHROID| HUMALOG U 100