FDA Adverse Event Malfunction Summary report: N

VITROS ECI IMMUNODIAGNOSTIC SYSTEM

MDR report key: 715601 · Received May 16, 2006

Report

Report Number: 1319681-2006-00110
Event Type: Malfunction
Date Received: May 16, 2006
Date of Event: March 23, 2006
Report Date: April 18, 2006
Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
Product Code: JJE
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION PROVIDED TO ORTHO-CLINICAL DIAGNOSTICS, INC MAY NOT BE VERIFIED OR VERIFIABLE, AND MAY BE INACCURATE OR INCOMPLETE AS REPORTED. THIS INFORMATION IS PROVIDED IN COMPLIANCE WITH THE MDR REGULATION, AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE HAS MALFUNCTIONED OR THAT A CONNECTION EXISTS BETWEEN THE PRODUCT AND A POTENTIAL DEATH OR SERIOUS INJURY. AN OCD FIELD ENGINEER VISITED THE SITE AND FOUND DRIED SIGNAL REAGENT ON THE INCUBATOR EVAPORATION COVER. THE SR DRAIN TUBE WAS LOOSE CAUSING SIGNAL REAGENT TO DRIP ON THE COVER. THE FE REPLACED THE PURGE STATION, TUBING AND FITTINGS. THE SERVICE ACTIONS HAVE RETURNED THE ANALYZER TO EXPECTED OPERATION. THE ROOT CAUSE OF THE EVENT IS INSTRUMENT RELATED.

Description of Event or Problem · 1

A CUSTOMER OBSERVED BIASED TSH RESULTS BETWEEN TWO PT SAMPLES DRAWN ON DIFFERENT DAYS. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VITROS ECI IMMUNODIAGNOSTIC SYSTEM	IMMUNODIAGNOSTIC ANALYZER	JJE	ORTHO-CLINICAL DIAGNOSTICS	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA