BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1585918 · Received January 21, 2010

    Report

    Report Number
    1823260-2010-00448
    Event Type
    Injury
    Date Received
    January 21, 2010
    Date of Event
    December 19, 2009
    Report Date
    April 27, 2010
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    DHA
    PMA / PMN Number
    K060373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. INSUFFICIENT INFORMATION WAS PROVIDED FOR INVESTIGATION OF THE EVENT. THE CUSTOMER SUSPECTED THERE WAS AN ADVERSE AFFECT ON THE PATIENT DUE TO THE HIGH BETA HCG RESULT BUT COULD NOT IDENTIFY IT. ACCORDING TO THE INFORMATION GIVEN, THE FIRST HIGH RESULT WAS QUESTIONED BECAUSE THE RESULT WAS NOT CONSISTENT WITH THE CLINICAL HISTORY, THEREFORE, THE TEST WAS REPEATED. CONSIDERING THE FACT THAT THE EXPECTED RESULTS WERE GENERATED BRIEFLY, WITHIN HALF AN HOUR, SERIOUS AFFECT ON THE PATIENT SEEMS UNLIKELY. NO ADVERSE EVENTS IN RELATION TO THE HIGH BETA HCG RESULT HAS BEEN REPORTED.

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL PT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    DURING THE REVIEW OF KNEE SURG SPORTS TRAUMATOL ARTHROSC PAPER, THE FOLLOWING CALAXO ISSUES WERE NOTED. PT PRESENTED POST-OPERATIVE CONDITION WITH A NEW ONSET OF PROMINENT LUMP AT THE SITE OF THE TIBIAL WOUND, 4-6 MONTHS FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED AN ERRONEOUS POSITIVE BETA HCG PT RESULT. WHEN CUSTOMER RAN THE SAME SAMPLE AGAIN, THE RESULT WAS NEGATIVE. INITIAL RESULTS WAS NOT CONSISTENT WITH THE CLINICAL HISTORY OF THE PT. THIS WAS A REQUIRED TEST PRIOR TO BEGINNING "CONCEPTIONAL TREATMENT" AND THE RESULT WAS EXPECTED TO BE NEGATIVE. INITIAL RESULT 74.33 (ACCOMPANIED BY DATA FLAG), REPEATED TWICE IN 2009, GAVE 4.89 (ACCOMPANIED BY DATA FLAG) AND 4.65 U/L (ACCOMPANIED BY DATA FLAG). SAMPLE WAS A SERUM ALIQUOT FROM A 13X75 PRIMARY TUBE. ACCORDING TO THE CUSTOMER, THE PT WAS ADVERSELY AFFECTED DUE TO THE HIGH FLIER. AFTER MULTIPLE REQUESTS, ADDITIONAL INFO REGARDING THE ADVERSE AFFECTS WERE NOT PROVIDED. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER -CEM DHA ROCHE DIAGNOSTICS CORP. E601

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK