COBAS 6000 C501 MODULE

MDR report key: 3893549 · Received June 25, 2014

Report

Report Number: 1823260-2014-04647
Event Type: Malfunction
Date Received: June 25, 2014
Date of Event: June 14, 2014
Report Date: June 25, 2014
Manufacturer: ROCHE DIAGNOSTICS
Product Code: JJE
PMA / PMN Number: K060373
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

Description of Event or Problem · 1

THE CUSTOMER EXPERIENCED ION SELECTIVE ELECTRODE (ISE) ISSUES OVER TWO WEEKS AND RECEIVED QUESTIONABLE RESULTS FOR THREE PATIENT SAMPLES. THE SAMPLES WERE REPEATED ON ANOTHER COBAS C501 ANALYZER. OF THE DATA PROVIDED, ONLY THE SODIUM RESULT FOR ONE PATIENT WAS DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE SAMPLES WERE PROCESSED BY THE MODULAR PREANALYTIC ANALYZER (MPA). THE INITIAL SODIUM RESULT WAS 132 MMOL/L AND THE REPEAT RESULT WAS 139 MMOL/L. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS IN THE ER AND THE CUSTOMER SPOKE TO THE ER PHYSICIAN DIRECTLY. NO TREATMENT WAS GIVEN IN RESPONSE TO THE INITIAL RESULTS AND THE PATIENT WAS RELEASED FROM THE ER. THERE WAS NO ADVERSE EVENT. THE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATES WERE REQUESTED, BUT WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND A SALT BUILD UP IN THE ISE HEAT BLOCK. HE CLEANED THE HEAT BLOCK AND THE ISE DRAIN AND HE ADJUSTED THE CUVETTE REGULATOR. HE RAN A PRECISION CHECK WITH RESULTS WITHIN SPECIFICATIONS. THE CUSTOMER RAN CALIBRATIONS AND QC WHICH WERE WITHIN SPECIFICATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
369893	COBAS 6000 C501 MODULE	CLINICAL CHEMISTRY ANALYZER	JJE	ROCHE DIAGNOSTICS	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1