BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3073154 · Received April 23, 2013

    Report

    Report Number
    1823260-2013-02476
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 1, 2013
    Report Date
    July 15, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER HAS STATED THAT HER DOCTOR HAS RELEASED HER FROM FURTHER TREATMENT WITH NO RESTRICTIONS ON ACTIVITY. THE USER NOTED THAT THE FIELD SERVICE REPRESENTATIVE HAS INSTALLED "LONGER HOSES" WATER LINES ON THE WATER TANK AND THIS HAS MADE IT EASIER TO REMOVE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE OPERATOR'S MANUAL PROVIDES A WARNING WITH REGARDS TO HANDLING THE WATER TANK. IT STATES THE FOLLOWING: "PERSONAL INJURY DUE TO HEAVY WATER TANK. THE WATER TANK, WHEN FILLED WITH WATER, IS HEAVY. HANDLE THE TANK ACCORDINGLY. IF THE TANK IS TOO HEAVY, POUR OUT SUFFICIENT WATER UNTIL THE TANK BECOMES LIGHT TO CARRY." THE USER HAD AN APPOINTMENT WITH THE ORTHOPEDIC DOCTOR ON (B)(6) 2013. HE PRESCRIBED 3 MORE WEEKS OF PHYSICAL THERAPY. THE BROKEN ELECTRICAL WIRES ON THE LEVEL SENSOR WHICH WERE FOUND BY THE FIELD SERVICE REPRESENTATIVE DID NOT CAUSE OR CONTRIBUTE TO THE INJURY.

    Additional Manufacturer Narrative · 1

    THE USER RETURNED TO THE DOCTOR ON (B)(4) 2013 AND THE DOCTOR NOTED THAT THE USER'S INJURY IS IMPROVING.

    Description of Event or Problem · 1

    THE USER CHANGED THE WATER TANK ON THE ANALYZER AND THEN RECEIVED A WATER LEVEL SENSOR MALFUNCTION ALARM. THE USER CHECKED IF WATER WAS IN THE TANK AND CONFIRMED THAT THERE WAS WATER PRESENT. THE USER RESEATED THE CAP TO THE TANK AND CHECKED THE FLOATS INSIDE THE TANK VERIFYING THAT THEY WERE MOVING FREELY. THE USER STATED THAT SHE "PULLED" HER BACK WHEN SHE LIFTED THE FULL TANK TO CHECK THE SENSOR. THE USER STATED THAT SHE WAS HAVING DIFFICULTY STANDING UP DUE TO THE PAIN. THE USER NOTIFIED HER HR DEPARTMENT AND WENT TO AN IMMEDIATE CARE CLINIC. AT THE IMMEDIATE CARE CLINIC, THE USER WAS TOLD TO USE A HEATING PAD AND TO TAKE AN ANTI-INFLAMMATORY. THE USER WAS ALSO OFFERED A NARCOTIC FOR THE PAIN, BUT DID NOT WANT TO TAKE THIS. SHE WAS RESTRICTED FROM BENDING AND LIFTING FOR TWO WEEKS AND TOLD TO FOLLOW UP WITH AN ORTHOPEDIC DOCTOR IN ONE TO TWO WEEKS IF SHE HAS NOT IMPROVED. THE USER VISITED THE ORTHOPEDIC DOCTOR ON (B)(6) 2013 AND HE PRESCRIBED TO HER THREE WEEKS OF PHYSICAL THERAPY. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THERE WERE BROKEN ELECTRICAL WIRES ON THE LEVEL SENSOR. HE REPLACED THE WIRES AND VERIFIED OPERATION BY RUNNING MECHANISM CHECKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173542 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR Required Intervention COUMADIN| EDARBI| METFORMIN| SYNTHROID| ZETIA