BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1680689 · Received May 12, 2010

    Report

    Report Number
    1823260-2010-02854
    Event Type
    Malfunction
    Date Received
    May 12, 2010
    Date of Event
    April 13, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THE CUSTOMER WAS UNABLE TO PROVIDE MEDICATIONS FOR PATIENT #2.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THE CUSTOMER PERFORMS SODIUM ANALYSIS ON THIS ANALYZER USING AN INDIRECT ISE MODE. THE CUSTOMER WAS COMPARING THESE RESULTS WITH THOSE FROM AN ANALYZER THAT USED A DIRECT ISE MODE. DUE TO THE SOLVENT EXCLUSION EFFECT IT IS NOT POSSIBLE TO COMPARE RESULTS OBTAINED THROUGH INDIRECT ISE MEASUREMENT WITH THOSE OBTAINED THROUGH DIRECT ISE MEASUREMENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED AN UNKNOWN NUMBER OF QUESTIONABLE SODIUM RESULTS ON THE COBAS INTEGRA 400 PLUS ANALYZER. THE CUSTOMER PROVIDED EXAMPLES OF 84 SODIUM RESULTS THAT HAD BEEN REPEATED ON ANOTHER ANALYZER. TWO OF THESE RESULTS WERE DISCREPANT: #1: INITIAL SODIUM = 130 MMOL/L #1: REPEAT SODIUM = 136 MMOL/L #2: INITIAL SODIUM = 123 MMOL/L #2: REPEAT SODIUM = 131 MMOL/L SODIUM ISE LOT #: 21594916 THE CUSTOMER STATED THAT IT IS UNKNOWN WHETHER OR NOT ANY PATIENTS WERE ADVERSELY AFFECTED. THE CUSTOMER DID STATE, THOUGH, THAT NEITHER OF THE DISCREPANT RESULTS PROVIDED WERE REPORTED OUTSIDE THE LABORATORY. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT NEVER HAD THERAPEUTIC EFFECT WHILE THE DEVICE WAS TURNED ON. STIMULATION IN THE WRONG LOCATION WAS ALSO NOTED. INITIALLY IT WAS REPORTED THAT THE WRONG AREA RECIVING STIMULATION WAS HIS BACK, BUT LATER IT WAS INDICATED THAT HE WAS ONLY FEELING STIMULATION ON RIGHT SIDE OF HIS LEG VS. THE LEFT SIDE. THE PT VISITED HIS HCP ON (B)(6) 2010, AND WAS INFORMED THAT A LEAD MIGRATION WAS SUSPECTED. A SURGICAL REVISION WAS PLANNED TO TAKE PLACE ON (B)(6) 2010. THE PT'S OUTCOME WAS NOT REPORTED. ADD'L INFO IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A F/U REPORT AT IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 046 YR LOTREL - ONCE DAILY| LISINOPRIL - TWICE DAILY| POTASSIUM - TWICE DAILY| LIPITOR -DAILY| LEVEMIR| COUMADIN| COREG - TWICE DAILY| LASIX - TWICE DAILY