BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK SPIRIT COMBO

    MDR report key: 2861525 · Received November 28, 2012

    Report

    Report Number
    2183996-2012-01815
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 18, 2012
    Report Date
    March 11, 2013
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. THE DELIVERY ACCURACY AND THE OCCLUSION LIMITS OF THE INSULIN PUMP WERE TESTED ON THE DIAGNOSTIC TEST SYSTEM AND BOTH MEET THE SPECIFICATIONS. THE ALARM FUNCTIONS OF THE INSULIN PUMP WERE TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEET THE SPECIFICATIONS. THE BUTTONS AND THE DISPLAY OF THE INSULIN PUMP WERE TESTED WITHIN THE MMI TEST ON THE DIAGNOSTIC TEST SYSTEM AND BOTH MEET THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE INITIATED.

    Description of Event or Problem · 1

    PATIENT REPORTED THE INFUSION DEVICE SWITCHED OFF BY ITSELF WITHOUT ANY ALARM OR ERROR MESSAGE. PATIENT STATED SHE IS EXPERIENCING ELEVATED BLOOD GLUCOSE LEVEL UP TO 450 MG/DL. PATIENT REPORTED THE INFUSION DEVICE GAVE AN ACOUSTIC ALERT AND DISPLAYED NO INFORMATION. PATIENT ALSO REPORTED EXPERIENCING DIFFICULTY OPENING THE BATTERY COVER. PATIENT STATED AFTER THE BATTERY AND BATTERY COVER WAS CHANGED, THE INFUSION DEVICE IS WORKING WITHOUT PROBLEMS. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHECK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR RELATED ACCESSORIES| DATE OF THERAPY: UNK| INSULIN| INSULIN INFUSION PUMP