inforMED
MalfunctionMSW

IMMULITE 2000 THYROGLOBULIN

Received Apr 27, 2018 · Event occurred Mar 29, 2018

Report 2432235-2018-00186 · MDR key 7469716

Device

Generic name

Immulite 2000 Thyroglobulin

Catalog number

L2KTY

Lot number

357

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THE INITIAL MDR 2432235-2018-00186 WAS FILED ON 02-APR-2018. ADDITIONAL INFORMATION (24-MAY-2018): SIEMENS TECHNICAL SUPPORT CENTER (TSC) WAS INFORMED BY THE CUSTOMER THAT THEY WERE UNABLE TO PROVIDE ANY SAMPLE FOR IN-HOUSE TESTING. HEADQUARTERS SUPPORT CENTER (HSC) HAS DETERMINED THAT INTERFERENCE FROM BIOTIN IS A POTENTIAL CAUSE BUT COULD NOT BE CONFIRMED AS THERE WAS NO SAMPLE PROVIDED BY THE CUSTOMER. THE CAUSE OF THE DISCORDANT THYROGLOBULIN RESULT(S) IS UNKNOWN.

Additional Manufacturer Narrative

A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE INSTRUMENT FILES FOR THE IMMULITE 2000 SYSTEM WERE CHECKED AND THE ADJUSTMENT AND QUALITY CONTROL SAMPLES WERE REVIEWED. THERE WERE NO PROBLEMS IDENTIFIED WITH THE INSTRUMENT. THE CUSTOMER WILL CONTINUE TO MONITOR THE INSTRUMENT. THE SYSTEM IS PERFORMING WITHIN SPECIFICATIONS. THE CAUSE OF THE DISCORDANT THYROGLOBULIN RESULT(S) IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE. MDR 2432235-2018-00187 IS BEING FILED FOR THE SAME EVENT.

Description of Event or Problem

DISCORDANT RESULTS WERE OBTAINED ON A PATIENT SAMPLE FOR THE THYROGLOBULIN (TG) ASSAY ON AN IMMULITE 2000 INSTRUMENT WHEN USING KIT LOT 357. THE SAMPLE WAS RUN NEAT WITH KIT LOT 353 AND THE RESULT WAS HIGH. A NEW BLOOD DRAW FROM THE SAME PATIENT WAS RUN ON THE SAME INSTRUMENT USING KIT LOT 357 AND THE RESULT WAS LOWER. THE SAMPLE WAS REPEATED AGAIN ON A DIFFERENT DATE (UNKNOWN IF IT WAS THE INITIAL SAMPLE OR THE SAMPLE FROM THE NEW BLOOD DRAW, OR ANOTHER NEW BLOOD DRAW) ON THE SAME IMMULITE 2000 INSTRUMENT AND THE RESULT WAS LOWER. THE TG KIT LOT USED TO RE-RUN THE SAMPLE WAS NOT PROVIDED. THE LOWER RESULTS WERE QUESTIONED BY THE PHYSICIAN(S). ALL THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN WHICH OF THE RESULTS IS THE EXPECTED RESULT ON THE PATIENT SAMPLE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THE DISCORDANT THYROGLOBULIN RESULTS.