FDA Adverse Event Malfunction Summary report: N

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

MDR report key: 2912079 · Received January 11, 2013

Report

Report Number: 3007111389-2013-00011
Event Type: Malfunction
Date Received: January 11, 2013
Date of Event: December 13, 2012
Report Date: January 11, 2013
Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
Product Code: MMI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION CONFIRMED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES PATIENT RESULT WAS OBTAINED WHILE USING THE VITROS 5600 SYSTEM. THERE IS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT. ADDITIONALLY, THE SAMPLE WAS NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATIONS. IT IS LIKELY THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, A SAMPLE PROCESSING ISSUE OR AN OPERATOR ERROR CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS.

Description of Event or Problem · 1

THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULT (0.236 VS. AN EXPECTED RESULT <0.012 NG/ML ) FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS 5600 SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE HIGHER THAN EXPECTED PATIENT RESULT WAS NOT REPORTED FROM THE LABORATORY. 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
17500	VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT	IN-VITRO DIAGNOSTIC	MMI	ORTHO-CLINICAL DIAGNOSTICS		1070

Patients

Seq	Age	Sex	Outcome	Treatment
1