BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI

    MDR report key: 1584801 · Received January 12, 2010

    Report

    Report Number
    1823260-2010-00144
    Event Type
    Malfunction
    Date Received
    January 12, 2010
    Date of Event
    December 14, 2009
    Report Date
    April 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJC
    PMA / PMN Number
    K945915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF CONTROL AND INSTRUMENT DATA PROVIDED INDICATED CONTROL RECOVERY FOR ALL 3 LEVELS OF CONTROLS FROM BEFORE AND AFTER THE EVENT WERE WITHIN SPECIFICATION AND THERE WAS NO INDICATION OF AN INSTRUMENT MALFUNCTION. TWO SAMPLE TYPES WERE USED FOR THE COMPARISON TESTS, WHOLE BLOOD ON COBAS B221 AND SERUM ON ABBOTT ARCHITECT. THE REPORTED DEVIATION MIGHT BE RELATED EITHER TO THE COMPARISON INSTRUMENT OR TO SOME OTHER EFFECTS WHICH COULD INFLUENCE THE BILIRUBIN MEASUREMENT RESULTS. BILIRUBIN IS INFLUENCED BY LIGHT THEREFORE THE SAMPLE MUST BE TRANSPORTED IN A LIGHT PROTECTOR, ESPECIALLY AFTER CENTRIFUGATION. IT IS UNCLEAR WHICH ANALYZER PROVIDED THE CORRECT BILIRUBIN RESULT. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    CUSTOMER PROVIDED PRINTOUTS OF THE BABY'S BILIRUBIN RESULTS AND DATES OF TESTING OBTAINED FROM DIFFERENT SAMPLES - NO REPEAT TESTING WAS PERFORMED ON THE SAME SAMPLE. BILIRUBIN RESULTS FROM OMNI BLOOD GAS ANALYZER: (B) (6) 2009 AT 12:57 GAVE 200 UMOL/L. (B) (6)2009 AT 14:33 GAVE 185 UMOL/L. (B) (6) 2009 AT 17:49 GAVE 132 UMOL/L. (B) (6) 2009 AT 07:41 GAVE 156 UMOL/L. BILIRUBIN RESULTS FROM "ARCATEC" LAB ANALYZER: (B) (6) 2009 AT 14:30 GAVE 64 UMOL/L. (B) (6) 2009 AT 10:15 GAVE 68 UMOL/L. CORRECTION TO DATE OF OCCURRENCE DOCUMENTED AS (B) (6) 2009 IN SUPPLEMENTAL MEDWATCH. CORRECT DATE OF OCCURRENCE IS (B) (6) 2009. CORRECTION TO "ARCETEC" BILIRUBIN RESULT OF 60 UMOL/L DOCUMENTED IN INITIAL MEDWATCH. CORRECT BILIRUBIN RESULT IS 64 UMOL/L.

    Description of Event or Problem · 1

    ACCOUNT ALLEGED THAT THE BED WILL DRIFT DOWN.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED A HIGHER TOTAL BILIRUBIN RESULT ON A SAMPLE OBTAINED FROM A BABY WHICH WAS LOWER WHEN REPLACED ON A DIFFERENT LAB ANALYZER "ARCETEC". AGE OF BABY AND DATE OF TESTING WERE NOT PROVIDED. INITIAL RESULT GAVE 200 UMOL PER L AND WAS REPORTED. THIS RESULT WAS QUESTIONED BY THE DOCTOR AS THE RESULT DID NOT MATCH THE BABY'S CONDITION. THE SAMPLE WAS REPEATED ON THE "ARCATEC" LAB ANALYZER GIVING 60 UMOL PER L WHICH WAS MORE IN LINE WITH THE BABY'S CONDITION. NO ADVERSE EVENTS WERE REPORTED. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI BLOOD GAS ANALYZER - JJC JJC ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK