1823260-2017-01311

MDR report key: 6662815 · Received June 23, 2017

Report

Report Number: 1823260-2017-01311
Event Type: Malfunction
Date Received: June 23, 2017
Date of Event: June 6, 2017
Report Date: July 9, 2017
PMA / PMN Number: K961481
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AU
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

UNIQUE IDENTIFIER (UDI)#: (B)(4). THIS EVENT OCCURRED IN (B)(6). PHONE WAS PROVIDED AS "(B)(6)".

Additional Manufacturer Narrative · 1

A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. THE ROOT CAUSE WAS MOST LIKELY DUE TO THE "LEANING" OF THE SAMPLE TUBE CAUSED THE AGE OF THE ROTOR OF THE ANALYZER AND WORN OUT OR BROKEN CLAMPS IN SPECIFIC ROTOR POSITIONS FOUND BY THE FIELD SERVICE REPRESENTATIVE. THE SAMPLE ROTOR WAS EXPECTED TO BE REPLACED. FROM THE INFORMATION PROVIDED, A GENERAL REAGENT ISSUE COULD MOST LIKELY BE EXCLUDED.

Description of Event or Problem · 1

THE CUSTOMER RECEIVED A QUESTIONABLE LOW ELECSYS TSH ASSAY RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.035 UIU/ML WITH A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. BASED ON THIS RESULT, FT4 AND FT3 WERE TESTED IN ANOTHER LABORATORY. THE TSH RESULT IN THE OTHER LABORATORY USING A COBAS 8000 E 602 MODULE WAS 1.28 MU/L. THE RESULTS FOR FT4 AND FT3 WERE NOT PROVIDED. ON (B)(6) 2017, THE SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER AND THE RESULTS WERE 1.28 UIU/ML AND 1.29 UIU/ML. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 220841. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. AS THE CUSTOMER WAS NOT USING THE MANDATORY SAMPLE RACK ADAPTERS, IT WAS ASSUMED THE ISSUE WAS DUE TO A TILTED POSITION OF THE SAMPLE TUBE WHICH CAUSED THE SAMPLE PIPETTOR TO NOT PIPET A SUFFICIENT SAMPLE VOLUME.

Patients

Seq	Age	Sex	Outcome	Treatment
1