BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 1844079 · Received September 24, 2010

    Report

    Report Number
    1823260-2010-05693
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    September 7, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    PT HAD A RIGHT-SIDED CHEST TUBE INSERTED IN THE AFTERNOON FOR A PNEUMOTHORAX. RESPIRATORY THERAPY IN TO ASSESS THE PATIENT'S RESPIRATORY STATUS DUE TO POOR AERATION AND DIMINISHED OXYGEN SATURATIONS. THE OXYGEN SATURATION(SPO2) WAS NOTED TO BE 64%. A NON-REBREATHER OXYGEN MASK WAS OBTAINED, THE PATIENT WAS GIVEN HIGH-FLOW OXYGEN VIA A NEBUILIZER TAKEN FROM HER SELF-ADMINISTERED NEBULIZER AND ATTACHED TO WALL OXYGEN. THE OXYGEN SATURATION (SPO2) IMPROVED TO ABOUT 80%. EQUIPMENT CHECK NOTED THE CHEST TUBE SUCTION TUBING WHICH CONNECTS THE SUCTION APPARATUS TO THE CHEST TUBE PLEURO-VAC WAS UNATTACHED AT THE SUCTION CANISTER. THE TUBING WAS EXPOSED TO AIR AND JUST A SMALL PART OF THE CONNECTOR WAS ATTACHED TO THE CANISTER. THE TUBING WAS RESECURED TO THE WALL SUCTION CANISTER. A NON-REBREATHER OXYGEN MASK WAS ATTACHED TO THE PATIENT AND WITH A FLOWRATE OF 15 LITERS PER MINUTE THE OXYGEN SATURATION (SPO2) SLOWLY RETURNED TO 91-94%. THE PATIENT WAS TRANSFERRED TO ICU FOR MANAGEMENT AS PNEUMOTHORAX WAS INCREASED QUESTIONABLY DUE TO THIS INCIDENT.======================HEALTH PROFESSIONAL'S IMPRESSION======================USE ERROR - SUCTION NOT CONNECTED PROPERLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE MOBILE SYSTEM WITHIN 10 MINUTES: 29.8 MMOL/L, 8.4 MMOL/L, AND 7.6 MMOL/L. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 277018

    Patients

    Seq Age Sex Outcome Treatment
    1 005 YR