FDA Adverse Event Malfunction Summary report: N

1319681-2018-00093

MDR report key: 7868431 · Received September 12, 2018

Report

Report Number: 1319681-2018-00093
Event Type: Malfunction
Date Received: September 12, 2018
Date of Event: August 17, 2018
Report Date: September 12, 2018
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: RP
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED QUALITY CONTROL RESULTS WERE OBTAINED FROM VITROS TOTAL THYROID CONTROL LOT 720 PROCESSED USING VITROS TSH REAGENT LOT 5700 IN COMBINATION WITH A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE ASSIGNABLE CAUSE FOR THE EVENT WAS DETERMINED TO BE AN INSTRUMENT ISSUE. AN ORTHO LABORATORY SPECIALIST PROCESSED A TEN REPLICATE PRECISION TEST USING VITROS TTC FLUIDS AND THE LEVEL 2 RESULTS WERE OUTSIDE ACCEPTABLE GUIDELINES INDICATING THE VITROS INSTRUMENT WAS NOT PERFORMING AS EXPECTED. AN ORTHO FIELD ENGINEER PERFORMED CHECKS AND ADJUSTMENTS TO THE WELL WASH, MICROWELL INCUBATOR, REAGENT METERING AND SIGNAL REAGENT SUBSYSTEMS. IN ADDITION, THE ORTHO FIELD ENGINEER REPLACED A VALVE TO THE UNIVERSAL WASH REAGENT RESERVOIR TO RESOLVE THIS ISSUE.

Description of Event or Problem · 1

A CUSTOMER OBTAINED HIGHER THAN EXPECTED, VITROS TSH RESULTS FROM A VITROS TOTAL THYROID CONTROL LOT 720 PROCESSED USING VITROS TSH REAGENT LOT 5700 IN COMBINATION WITH A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. VITROS TTC LOT 720 LEVEL 2 = 2.87, 2.85 MIU/L VERSUS EXPECTED 2.03 MIU/L BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. ORTHO HAS NOT BEEN MADE AWARE OF ANY ERRONEOUS VITROS TSH PATIENT RESULTS OBTAINED OR REPORTED FROM THE LABORATORY OVER THE TIME FRAME OF THE EVENT. THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

Patients

Seq	Age	Sex	Outcome	Treatment
1