FDA Adverse Event Malfunction Summary report: N

VITROS 5600 INTEGRATED SYSTEM

MDR report key: 3771187 · Received April 24, 2014

Report

Report Number: 1319681-2014-00074
Event Type: Malfunction
Date Received: April 24, 2014
Date of Event: February 13, 2014
Report Date: April 24, 2014
Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
Product Code: JJE
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION DETERMINED THAT A DISCORDANT NEGATIVE VITROS AMPH RESULT WAS REPORTED FOR A SINGLE PROFICIENCY SAMPLE RUN ON THE VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THIS EVENT WAS USER ERROR. THE OPERATOR INCORRECTLY INTERPRETED THE ANALYZER¿S CONDITION CODE U91-200 AS INDICATING A NEGATIVE AMPH RESULT WHEN THE ANALYZER WAS IN FACT UNABLE TO GENERATE AN AMPH RESULT, DUE MOST LIKELY TO HIGH ACTIVITY OF THE SAMPLE BEING ABOVE THE MEASURING RANGE. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST THAT EITHER THE VITROS 5600 SYSTEM OR THE VITROS AMPH REAGENT MALFUNCTIONED. THE ASSIGNABLE CAUSE OF THE EVENT WAS USER ERROR.

Description of Event or Problem · 1

THE CUSTOMER REPORTED A DISCORDANT NEGATIVE VITROS AMPH RESULT FROM A SINGLE PROFICIENCY SAMPLE RUN ON THE VITROS 5600 INTEGRATED SYSTEM. THE NEGATIVE VITROS AMPH RESULT WAS CONSIDERED TO BE DISCORDANT AS THE PROFICIENCY SAMPLE WAS EXPECTED TO BE POSITIVE FOR AMPHETAMINES. NO PATIENT SAMPLES WERE REPORTED TO HAVE BEEN AFFECTED. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
250069	VITROS 5600 INTEGRATED SYSTEM	CHEMISTRY ANALYZER	JJE	ORTHO-CLINICAL DIAGNOSTICS

Patients

Seq	Age	Sex	Outcome	Treatment
1