BEUDAMED
    FDA Adverse Event Summary report: N

    VITROS CHEMISTRY PRODUCTS NA+ REAGENT

    MDR report key: 3944782 · Received July 18, 2014

    Report

    Report Number
    1319809-2014-00030
    Date Received
    July 18, 2014
    Date of Event
    June 20, 2014
    Report Date
    July 18, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JGS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDES THAT A HIGHER THAN EXPECTED VITROS NA RESULT WAS OBTAINED FROM A SINGLE NEONATE PATIENT ON A VITROS 5600 INTEGRATED SYSTEM. THE HIGHER THAN EXPECTED VITROS NA RESULT WAS REPORTED OUTSIDE OF THE LABORATORY, AND TREATMENT WAS INITIATED BASED ON THE REPORTED VITROS RESULT. THE ASSIGNABLE CAUSE OF THE EVENT IS MOST LIKELY AN ISSUE WITH THE VITROS NA+ REAGENT LOT 4222-0904-2453 (GEN 22) REAGENT. ACCEPTABLE VITROS NA+ PERFORMANCE WAS OBTAINED AFTER PUTTING AN ALTERNATE GEN OF VITROS NA+ SLIDES (GEN23) INTO USE. THE INVESTIGATION OF THIS ISSUE IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A HIGHER THAN EXPECTED VITROS NA+ RESULT FROM A SINGLE NEONATAL PATIENT SAMPLE ON A VITROS 5600 INTEGRATED SYSTEM, COMPARED TO A NA+ RESULT OBTAINED FROM A NON-VITROS METHOD. PATIENT: VITROS NA+ RESULT OF 149 MMOL/L VS. NON-VITROS RESULT OF 137 MMOL/L. THE VITROS NA+ RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND TREATMENT WAS INITIATED BASED ON THE HIGHER THAN EXPECTED RESULT. THE PATIENT WAS GIVEN IV FLUID TREATMENT AS A RESULT OF THE HIGHER THAN EXPECTED VITROS NA+ RESULT THAT WAS REPORTED. THE ATTENDING PHYSICIAN DID NOT RESPOND TO MULTIPLE REQUESTS CONCERNING THE CURRENT CONDITION OF THE PATIENT. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. HOWEVER, A FALSELY ELEVATED NA TEST RESULT COULD POTENTIALLY MISS THE DIAGNOSIS OF HYPONATREMIA OR UNDER ESTIMATE THE SEVERITY OF HYPONATREMIA, AND COULD POTENTIALLY LEAD TO SERIOUS HEALTH RISKS TO PATIENT, ESPECIALLY WITH PRETERM NEONATES. THEREFORE, BASED ON THE LIMITED INFORMATION PROVIDED AND USING THE WORST CASE SCENARIO, THIS EVENT COULD POTENTIALLY LEAD TO PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422861 VITROS CHEMISTRY PRODUCTS NA+ REAGENT IN-VITRO DIAGNOSTIC JGS ORTHO-CLINICAL DIAGNOSTICS 4222-0904-2453

    Patients

    Seq Age Sex Outcome Treatment
    1