FDA Adverse Event Malfunction Summary report: N

VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

MDR report key: 2924810 · Received January 22, 2013

Report

Report Number: 1319681-2013-00035
Event Type: Malfunction
Date Received: January 22, 2013
Date of Event: November 13, 2012
Report Date: January 21, 2013
Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
Product Code: KHO
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION DETERMINED THAT A PARTICULATE FILTER WAS INSTALLED IN PLACE OF A VAPOR ADSORPTION CARTRIDGE ON A VITROS ECIQ SYSTEM. THERE WAS NO EVIDENCE TO SUGGEST AN INSTRUMENT ISSUE OR A REAGENT RELATED ISSUE HAD CONTRIBUTED TO THE EVENT. THE ROOT CAUSE OF THE INADVERTENT EVENT IS INCORRECT PACKAGING OF THE PARTICULATE FILTERS IN VAC SALES CARTONS BY OCD. THE CUSTOMER HAS NOT REPORTED ANY PERFORMANCE ISSUES SINCE THE REPLACEMENT OF THE PARTICULATE FILTER WITH THE VAC ON THE VITROS ECIQ SYSTEM. THE ISSUE HAS BEEN COMMUNICATED TO CUSTOMERS THROUGH CUSTOMER LETTER (B)(4). THE FDA'S (B)(4) DISTRICT OFFICE WAS NOTIFIED OF THIS ISSUE ON 20-DECEMBER-2012 PER RECALL NUMBER 1319681-12/20/2012-001-C.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT A PARTICULATE FILTER WAS INSTALLED IN PLACE OF A VAPOR ADSORPTION CARTRIDGE ON A VITROS ECIQ SYSTEM. BIASED RESULTS PREDICTED WITH A PARTICULATE FILTER IN PLACE OF A VAPOR ADSORPTION CARTRIDGE ON THE ANALYZER MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THERE WAS NO REPORT THAT PATIENT RESULTS 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
30274	VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM	IMMUNODIAGNOSTIC ANALYZER	KHO	ORTHO-CLINICAL DIAGNOSTICS

Patients

Seq	Age	Sex	Outcome	Treatment
1