FDA Adverse Event Malfunction Summary report: N

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

MDR report key: 1894875 · Received November 10, 2010

Report

Report Number: 3007111389-2010-00016
Event Type: Malfunction
Date Received: November 10, 2010
Date of Event: October 11, 2010
Report Date: November 10, 2010
Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
Product Code: MMI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION CONFIRMED THAT NON-REPRODUCIBLE, FALSELY ELEVATED VITROS TROP I ES RESULTS WERE OBTAINED. THE INVESTIGATION DETERMINED THAT THE SAMPLES INVOLVED MAY NOT HAVE BEEN PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATION. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. MAINTENANCE PERFORMED TO THE EQUIPMENT WAS UNLIKELY TO HAVE CONTRIBUTED TO THE EVENT. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. HOWEVER, PRE-ANALYTICAL SAMPLE PROCESSING CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

Description of Event or Problem · 1

THIS CUSTOMER OBTAINED NON-REPRODUCIBLE, FALSELY ELEVATED VITROS TROP I ES RESULTS FOR MULTIPLE PATIENT SAMPLES WHILE USING THE VITROS ECIQ IMMUNODIAGNOSTIC ANALYZER. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE ORIGINAL RESULTS WERE NOT REPORTED TO THE CLINICIAN. THERE WAS NO ALLEGATION OF HARM TO PATIENTS AS A RESULT OF THIS EVENT. 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 IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT	IN-VITRO DIAGNOSTIC	MMI	ORTHO-CLINICAL DIAGNOSTICS		0557

Patients

Seq	Age	Sex	Outcome	Treatment
1