FDA Adverse Event Malfunction Summary report: N

VITROS IMMUNODIAGNOSTIC PRODUCTS CKMB REAGENT

MDR report key: 2930192 · Received January 25, 2013

Report

Report Number: 3007111389-2013-00024
Event Type: Malfunction
Date Received: January 25, 2013
Date of Event: December 12, 2012
Report Date: January 25, 2013
Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
Product Code: JHX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: HI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION CONFIRMED THAT UNEXPECTED QUALITY CONTROL RESULTS WERE OBTAINED ACROSS MULTIPLE ASSAYS PROCESSED ON A VITROS 5600 SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE CAUSE. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST AN INSTRUMENT OR REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT. NO FURTHER OCCURRENCE OF THIS ISSUE HAS BEEN REPORTED SINCE (B)(6) 2013. THE ROOT CAUSE OF THE EVENT IS UNKNOWN.

Description of Event or Problem · 1

THE CUSTOMER OBTAINED MULTIPLE, UNEXPECTED QUALITY CONTROL RESULTS ACROSS MULTIPLE ASSAYS PROCESSED ON A VITROS 5600 SYSTEM. UNEXPECTED VITROS CKMB QUALITY CONTROL RESULTS (QC LOT 1106180B = 2.067, 2.051, 2.448 VS. AN EXPECTED RESULT = 2.189 NG/ML) AND VITROS TOTAL BHCG II QUALITY CONTROL RESULTS (QC LOT 40783 = 32.276 VS. AN EXPECTED RESULT= 508.353 MIU/ML) WERE OBSERVED. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED ON PATIENT SAMPLES. IT IS UNKNOWN IF PATIENT SAMPLES WERE AFFECTED. HOWEVER, THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
35786	VITROS IMMUNODIAGNOSTIC PRODUCTS CKMB REAGENT	IN-VITRO DIAGNOSTIC	JHX	ORTHO-CLINICAL DIAGNOSTICS		1420

Patients

Seq	Age	Sex	Outcome	Treatment
1