FDA Adverse Event Malfunction Summary report: N

VITROS CHEMISTRY PRODUCTS VALP REAGENT

MDR report key: 2071097 · Received April 27, 2011

Report

Report Number: 1319808-2011-00012
Event Type: Malfunction
Date Received: April 27, 2011
Date of Event: March 29, 2011
Report Date: April 27, 2011
Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
Product Code: LEG
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS VALP RESULTS WERE OBTAINED FOR MULTIPLE PATIENT SAMPLES PROCESSED ON THE VITROS 5,1 FS CHEMISTRY SYSTEM WHEN COMPARED TO ALTERNATE VALPROIC ACID METHODS. THE ROOT CAUSE IS REAGENT RELATED DUE TO THE VITROS VALP REAGENT LOT VALUE ASSIGNMENT PROCESS. OCD IS CURRENTLY IDENTIFYING ACTIONS TO ADDRESS THE NEGATIVE BIAS OF VITROS VALP PATIENT RESULTS COMPARED TO ALTERNATE METHODS.

Description of Event or Problem · 1

INTERNAL TESTING PERFORMED BY OCD PRODUCT SUPPORT GENERATED LOWER THAN EXPECTED VITROS VALP RESULTS FOR MULTIPLE PATIENT SAMPLES PROCESSED ON THE VITROS 5,1 FS CHEMISTRY SYSTEM WHEN COMPARED TO ALTERNATE VALPROIC ACID METHODS. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE LOWER THAN EXPECTED RESULTS WERE GENERATED DURING INTERNAL TESTING, THEREFORE PATIENT TREATMENT WAS NOT AFFECTED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER SIX OF SIX MDRS FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX DEVICES WERE INVOLVED. 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 CHEMISTRY PRODUCTS VALP REAGENT	IN-VITRO DIAGNOSTIC	LEG	ORTHO-CLINICAL DIAGNOSTICS		1511-14-9637

Patients

Seq	Age	Sex	Outcome	Treatment
1