FDA Adverse Event Malfunction Summary report: N

VITROS 5,1 FS CHEMISTRY SYSTEM

MDR report key: 2883709 · Received December 21, 2012

Report

Report Number: 1319681-2012-00258
Event Type: Malfunction
Date Received: December 21, 2012
Date of Event: November 27, 2012
Report Date: December 21, 2012
Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
Product Code: JJE
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: MEDICAL TECHNOLOGIST

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION CONFIRMED THAT HIGHER THAN EXPECTED VITROS AMON RESULTS WERE PREDICTED FROM A QUALITY CONTROL FLUID WHILE USING THE VITROS 5,1 FS SYSTEM. INVESTIGATION DETERMINED THE MOST LIKELY ASSIGNABLE CAUSE WAS ATTRIBUTED TO AN EQUIPMENT RELATED ISSUE (INCUBATOR CONTAMINATION). AN OPERATOR INAPPROPRIATELY USED AN AMMONIA BASED CLEANER WHILE PERFORMING INSTRUMENT MAINTENANCE WHICH IS NOT IN ACCORDANCE WITH THE VITROS 5,1 FS CHEMISTRY SYSTEM USER DOCUMENTATION. AFTER CLEANING THE MICROSLIDE INCUBATOR AND RECALIBRATING THE VITROS AMON SLIDE LOT, ACCEPTABLE PERFORMANCE WAS OBSERVED.

Description of Event or Problem · 1

THE CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS AMON (AMMONIA) QUALITY CONTROL RESULTS WHILE USING A VITROS 5,1 FS CHEMISTRY SYSTEM. VITROS AMON RESULTS OF 225.8, 224.8, 227.5, 228.0, 225.8, 230.0, 249.7, AND 225.6 MMOL/L VS. THE EXPECTED RESULT OF 187.1 MMOL/L WERE PREDICTED. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION, SHOULD THEY OCCUR UNDETECTED ON PATIENT SAMPLES. THE CUSTOMER DID NOT INDICATE THAT PATIENT RESULTS WERE AFFECTED AND THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM. (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