FDA Adverse Event Malfunction Summary report: N

1319681-2017-00044

MDR report key: 6621265 · Received June 8, 2017

Report

Report Number: 1319681-2017-00044
Event Type: Malfunction
Date Received: June 8, 2017
Date of Event: May 10, 2017
Report Date: June 8, 2017
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: MEDICAL TECHNOLOGIST

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION DETERMINED THAT LOWER AND HIGHER THAN EXPECTED VITROS PHYT RESULTS WERE OBTAINED FROM VITROS AND NON-VITROS QUALITY CONTROL MATERIALS USING A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE OF THIS EVENT WAS INSTRUMENT RELATED, AS THE VITROS DGXN WITHIN-RUN PRECISION TEST PERFORMED TO ASSESS THE INSTRUMENT'S PERFORMANCE WAS OUTSIDE THE ORTHO'S RECOMMENDED GUIDELINES. AN ORTHO FIELD ENGINEER PERFORMED SERVICE ACTIONS WHICH INCLUDED THE CLEANING OF THE SLIDE INCUBATOR, REFLECTOMETER LENS AND IMMUNOWASH FLUID (IWF) ASSEMBLIES, LUBRICATED THE IWF PUMP AND REPLACED IWF TUBING. FOLLOWING THESE ACTION, ACCEPTABLE VITROS PHYT QUALITY CONTROL RESULTS WERE OBSERVED. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY ASSIGNABLE CAUSE OF THIS EVENT WAS INSTRUMENT RELATED.

Description of Event or Problem · 1

THE CUSTOMER OBTAINED LOWER AND HIGHER THAN EXPECTED PHYT QUALITY CONTROL RESULTS USING A VITROS 5600 INTEGRATED SYSTEM (UNITS ARE G/ML): (B)(6). BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE LOWER AND HIGHER THAN EXPECTED VITROS PHYT RESULTS WERE GENERATED FROM QUALITY CONTROL FLUIDS. PATIENT SAMPLES WERE NOT PROCESSED AS THE QUALITY CONTROL RESULTS WERE OUTSIDE OF ACCEPTABLE RANGES. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM. (B)(4).

Patients

Seq	Age	Sex	Outcome	Treatment
1