BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1841750 · Received September 22, 2010

    Report

    Report Number
    1823260-2010-05633
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER FROM INFORM SYSTEM USER FACILITY REPORTED NEONATE PATIENT BLOOD GLUCOSE RESULTS: 8:01 - 39 MG/DL 8:06 - 37 MG/DL 8:10 LAB DRAW - 19 MG/DL CONTROLS WERE RUN DAY BEFORE INCIDENT AND AGAIN DAY OF/AFTER THE INCIDENT. BOTH LEVELS PASSED. THE BABY WAS JAUNDICED WHEN BORN, BUT WAS TREATED FOR THIS. THE BABY WAS SYMPTOMATIC OF LOW BLOOD, WAS TREATED BASED ON THE LAB RESULT OF 19 MG/DL. THIS WASN'T A FASTING RESULT. NO HEMATOCRIT RESULTS PROVIDED. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER, STRIPS, AND CONTROLS, REPLACEMENT SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE DEVICE HAD A FROZEN DISPLAY AND UNRESPONSIVE BUTTONS. THE INSULIN PUMP RESTED FOR COUPLE HOURS AND THE ERROR ALARM CONTINUED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551250

    Patients

    Seq Age Sex Outcome Treatment
    1 003 DA