1823260-2017-01418

MDR report key: 6696585 · Received July 10, 2017

Report

Report Number: 1823260-2017-01418
Event Type: Malfunction
Date Received: July 10, 2017
Date of Event: June 22, 2017
Report Date: August 5, 2017
PMA / PMN Number: K060373
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: MEDICAL TECHNOLOGIST

Narratives

Additional Manufacturer Narrative · 1

UNIQUE IDENTIFIER (UDI)#: (B)(4)

Additional Manufacturer Narrative · 1

THE CUSTOMER HAS HAD NO FURTHER ISSUES WITH UA2 RESULTS. THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE AN ISSUE WITH THE SAMPLE PROBE WITH WASH WATER ADJUSTMENTS/MAINTENANCE. THE ISSUES IDENTIFIED BY THE FSE EXPLAIN THE OBSERVED BEHAVIOR.

Description of Event or Problem · 1

THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR UA2 URIC ACID VER.2 (UA2) ON A COBAS 6000 C (501) MODULE. THE INITIAL UA2 RESULT WAS "<0.2 L" WITH A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS 3.9 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE CUSTOMER IS NOT AWARE OF ANY ADVERSE EVENT FOR THIS PATIENT. THE UA2 REAGENT LOT NUMBER WAS 172896. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE. REACTION CELL DUST WAS FALLING INTO CELLS FROM RUBBING THE CELL COVER. THE FSE STRAIGHTENED THE COVER AND CHECKED ALL PUMP PRESSURES, RINSE VOLUMES AND PROBE ALIGNMENTS. MECHANISM AND AIR PURGES PASSED. THE CUSTOMER RAN SUCCESSFUL QUALITY CONTROLS.

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR