1823260-2017-01788

MDR report key: 6809926 · Received August 22, 2017

Report

Report Number: 1823260-2017-01788
Event Type: Malfunction
Date Received: August 22, 2017
Date of Event: August 1, 2017
Report Date: August 22, 2017
PMA / PMN Number: K100853
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(6). (B)(4).

Description of Event or Problem · 1

THE CUSTOMER STATED THAT THEY NOTICED QUESTIONABLE RESULTS FOR SOME PATIENT SAMPLES TESTED FOR ALB2 ALBUMIN GEN.2 (ALB) ON THE COBAS 8000 C (701) MODULE - C701. THIS PROMPTED THEM TO REPEAT 1000 PATIENT SAMPLES. THE CUSTOMER PROVIDED DATA FOR TWO PATIENT SAMPLES THAT WERE QUESTIONED. OF THESE, ONE HAD AN ERRONEOUS RESULT. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER ALSO STATED THAT THEY WERE SEEING ERRATIC BEHAVIOR FOR THE ENZYMATIC CREATININE TEST RUN ON THE OTHER DISK OF THE ANALYZER. NO FURTHER DETAILS WERE PROVIDED REGARDING THIS. THE SAMPLE INITIALLY RESULTED WITH AN ALB VALUE OF 58.6 G/L. THE SAMPLE WAS REPEATED ON (B)(6) 2017, RESULTING AS 39.3 G/L. THE SAMPLE WAS ALSO REPEATED ON (B)(6) 2017, RESULTING AS 40.8 G/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE CUSTOMER RAN PRECISION STUDIES. THE CUSTOMER CHANGED ALL REAGENT AND SAMPLE PROBES. THESE ACTIONS DID NOT RESOLVE THE ISSUE. THE FIELD SERVICE ENGINEER CHECKED WASHING ON THE ANALYZER AND THIS WAS OK. HE CHECKED GEAR PUMP PRESSURE AND PROBE WASHING AND THESE WERE OK. HE CHECKED THE HIGH CONCENTRATION VACUUM AND PRESSURE WAS A BIT LOW. HE REPLACED A VALVE AND DAMAGED TUBING. CALIBRATION AND QUALITY CONTROLS WERE OK. THE ISSUE WAS DUE TO AGING OF THE REPLACED VALVE.

Patients

Seq	Age	Sex	Outcome	Treatment
1