COBAS 8000 CORE UNIT

MDR report key: 4170043 · Received October 14, 2014

Report

Report Number: 1823260-2014-07859
Event Type: Malfunction
Date Received: October 14, 2014
Date of Event: August 25, 2014
Report Date: October 14, 2014
Manufacturer: ROCHE DIAGNOSTICS
Product Code: JJE
PMA / PMN Number: K100853
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem · 1

THE CUSTOMER RECEIVED QUESTIONABLE THYROID RESULTS FOR ONE PATIENT. OF THE DATA PROVIDED, THE FREE TRIIODOTHYRONINE (FT3) RESULTS WERE DISCREPANT. THREE SAMPLES WERE COLLECTED FROM THE PATIENT. (B)(6) 2014: FT3 RESULT WAS 3.4 PG/ML. (B)(6) 2014: FT3 RESULT WAS 3.3 PG/ML. (B)(6) 2014: FT3 RESULT WAS 3.6 PG/ML. A SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION. THE COLLECTION DATE OF THE SAMPLE WAS UNKNOWN. THE FT3 RESULT BY CLIA METHOD ON A CENTAUR ANALYZER WAS 4.4 PG/ML. PEG TREATMENT WAS PERFORMED ON THE SAMPLE AND THE RECOVERY WAS 75.3%. INFORMATION CONCERNING IF ANY ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY OR IF THE PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED, BUT WAS NOT PROVIDED. THE FT3 REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT WERE NOT PROVIDED. AS NO ADDITIONAL PATIENT SAMPLE WAS AVAILABLE, FURTHER INVESTIGATION WAS NOT POSSIBLE. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. A GENERAL REAGENT ISSUE COULD MOST LIKELY BE EXCLUDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
650892	COBAS 8000 CORE UNIT	CLINICAL CHEMISTRY ANALYZER	JJE	ROCHE DIAGNOSTICS	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	046 YR