COBAS 6000 C501 MODULE

MDR report key: 4781209 · Received May 19, 2015

Report

Report Number: 1823260-2015-03493
Event Type: Malfunction
Date Received: May 19, 2015
Date of Event: May 8, 2015
Report Date: May 19, 2015
Manufacturer: ROCHE DIAGNOSTICS
Product Code: JJE
PMA / PMN Number: K060373
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR MAGNESIUM. THE SAMPLE, FROM A CUP PROCESSED ON A PRE-ANALYTICS SYSTEM, INITIALLY RESULTED AS 3.1 MG/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER REPEATED THE SAMPLE BASED ON A DELTA CHECK FLAG. THE PRIMARY TUBE OF THE SAMPLE WAS REPEATED TWICE, EACH TIME ON A DIFFERENT C501 ANALYZER, RESULTING AS 1.9 MG/DL EACH TIME. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE CUSTOMER WAS ASKED, BUT DID NOT KNOW IF THE PATIENT WAS ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE ALLEGED. THE MAGNESIUM REAGENT LOT NUMBER WAS 60611501, WITH AN EXPIRATION DATE OF 07/31/2016. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT A DETERGENT CONNECTOR WAS LEAKING. HE CLEANED AND RE-SEATED THE DETERGENT. HE CHECKED AND ADJUSTED THE INTERNAL AND EXTERNAL RINSE WATER. HE CLEANED THE RINSE NOZZLES. HE RAN PRECISION TESTING AND ALL RESULTS WERE WITHIN ACCEPTABLE LIMITS. THE CUSTOMER RAN CALIBRATION AND QUALITY CONTROLS; ALL RESULTS WERE WITHIN ACCEPTABLE LIMITS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
325630	COBAS 6000 C501 MODULE	CLINICAL CHEMISTRY ANALYZER	JJE	ROCHE DIAGNOSTICS	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1