FDA Adverse Event Malfunction Summary report: N

VITROS 5,1 FS CHEMISTRY SYSTEM

MDR report key: 2190157 · Received August 4, 2011

Report

Report Number: 1319681-2011-00156
Event Type: Malfunction
Date Received: August 4, 2011
Date of Event: July 11, 2011
Report Date: August 4, 2011
Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
Product Code: JJE
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION CONFIRMED THAT LOWER THAN EXPECTED VANC QUALITY CONTROL RESULTS WERE OBTAINED WHILE USING THE VITROS 5,1 FS ANALYZER. TROUBLESHOOTING WITH THE CUSTOMER DETERMINED THAT THE PHOTOMETER LAMP REQUIRED REPLACEMENT. HOWEVER, THE CUSTOMER REMOVED THEN RE-INSTALLED THE SAME LAMP THAT WAS IN USE AT THE TIME OF THE EVENT. PERFORMANCE TESTING FOLLOWING RE-INSTALLATION OF THE PHOTOMETER LAMP VERIFIED THAT THE EQUIPMENT WAS OPERATING AS EXPECTED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, THE MOST LIKELY ASSIGNABLE CAUSE IS AN EQUIPMENT RELATED ISSUE.

Description of Event or Problem · 1

THE CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS VANC QUALITY CONTROL RESULTS (LIQUID PV1 RESULT OF < 5.0 UG/ML VS EXPECTED RESULT OF 8.06 UG/ML; LIQUID PV2 RESULT OF 22.28 UG/ML VS EXPECTED RESULT OF 33.84 UG/ML) WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENTS WERE TO RECUR WITH PATIENT SAMPLES. NO VANC PATIENT RESULTS WERE KNOWN TO BE AFFECTED. THERE WAS NO ALLEGATION OF HARM TO PATIENTS AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC COMPLAINT NUMBER (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VITROS 5,1 FS CHEMISTRY SYSTEM	CHEMISTRY ANALYZER	JJE	ORTHO-CLINICAL DIAGNOSTICS

Patients

Seq	Age	Sex	Outcome	Treatment
1				NOT APPICABLE.