EVOLIS MICROPLATE SYSTEM

Report

Report Number: 3022521-2013-00002
Event Type: Other
Date Received: August 20, 2013
Date of Event: July 24, 2013
Report Date: August 19, 2013
Manufacturer: BIO-RAD LABORATORIES, INC.
Product Code: LOL
PMA / PMN Number: K092353
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

ON (B)(6) 2013, A CUSTOMER CALLED BIO-RAD LABORATORIES TECHNICAL SUPPORT DEPARTMENT TO REPORT THAT WHEN REPORTING RESULTS FROM AN (B)(6) TESTING RUN, THEY MADE A TRANSCRIPTION ERROR. THIS TRANSCRIPTION ERROR RESULTED IN THE CUSTOMER INCORRECTLY REPORTING A PT AS (B)(6) WHEN THE SAMPLE WAS ACTUALLY INITIALLY (B)(6) ON THE (B)(6). THE CUSTOMER REPORTED THAT THE (B)(6) TESTING RUN INVOLVED IN THE ISSUE INCLUDED A NUMBER OF SAMPLES, THREE OF WHICH WERE BEING TESTED IN DUPLICATE FOLLOWING INITIALLY (B)(6) RESULTS. THE SAMPLE INVOLVED IN THE TRANSCRIPTION ERROR WAS A NEW PT SAMPLE THAT WAS COINCIDENTALLY RUN DIRECTLY ADJACENT TO THE THREE PREVIOUSLY INITIALLY (B)(6) SAMPLES. WHEN REVIEWING THE ASSAY RESULTS REPORT, THE TECHNICIAN ACCIDENTALLY ASSOCIATED THE NEW PT SAMPLE IDENTITY WITH OTHER NON-REACTIVE PT SAMPLES THAT WERE LOCATED ON THE SAME RESULTS REPORT. SAMPLES IMMEDIATELY BELOW THE NEW INITIALLY (B)(6) PT SAMPLE WERE NON-REACTIVE. THE CUSTOMER REPORTED THAT THE ASSAY RUN WAS VALID AND THE INSTRUMENT WAS PERFORMING ACCURATELY. THE PT SAMPLE INVOLVED IN THE TRANSCRIPTION ERROR WAS INITIALLY TESTED ON (B)(6) 2013. THE TRANSCRIPTION ERROR WAS DISCOVERED BY THE CUSTOMER WHEN THE PT WAS TESTED AGAIN SIX MONTHS LATER ON (B)(6) 2013 AND A REPEATEDLY (B)(6) RESULT WAS OBTAINED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
403380	EVOLIS MICROPLATE SYSTEM	4PS SYSTEM	LOL	BIO-RAD LABORATORIES, INC.	EVOLIS

Patients

Seq	Age	Sex	Outcome	Treatment
1