FDA Adverse Event Malfunction Summary report: N

VITROS CHEMISTRY PRODUCTS GLU SLIDES

MDR report key: 2174544 · Received July 24, 2011

Report

Report Number: 1319809-2011-00095
Event Type: Malfunction
Date Received: July 24, 2011
Date of Event: June 21, 2011
Report Date: July 20, 2011
Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
Product Code: CGA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION DETERMINED THAT MULTIPLE, LOWER THAN EXPECTED VITROS GLU PATIENT RESULTS WERE OBTAINED. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED, HOWEVER, THE MOST LIKELY CAUSE IS A SLIDE REAGENT RELATED ISSUE. PERFORMANCE TESTING DEMONSTRATED THAT THE VITROS 5,1 FS ANALYZER WAS OPERATING AS EXPECTED AND DID NOT MALFUNCTION.

Description of Event or Problem · 1

A CUSTOMER OBSERVED MULTIPLE, LOWER THAN EXPECTED VITROS GLU RESULTS FROM MULTIPLE PATIENT SAMPLES AND QUALITY CONTROLS (FIVE PATIENT RESULTS OF < 20 MG/DL VS. REPEAT RESULTS OF 133, 126, 133, 240, AND 199 MG/DL; TWO QC RESULTS OF < 20 MG/DL VS. EXPECTED RESULTS OF 86.6 AND 292.1 MG/DL) WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED PATIENT RESULTS WERE NOT REPORTED TO THE CLINICIAN. THERE WAS NO ALLEGATION OF HARM TO PATIENTS AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF SEVEN MDRS FOR THIS EVENT. SEVEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVEN 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 GLU SLIDES	IN-VITRO DIAGNOSTIC	CGA	ORTHO-CLINICAL DIAGNOSTICS		0025-0797-2109

Patients

Seq	Age	Sex	Outcome	Treatment
1				NOT APPLICABLE.