FDA Adverse Event Malfunction Summary report: N

ELECSYS TSH ASSAY

MDR report key: 8168559 · Received December 17, 2018

Report

Report Number: 1823260-2018-04903
Event Type: Malfunction
Date Received: December 17, 2018
Date of Event: November 16, 2018
Report Date: January 28, 2019
Manufacturer: ROCHE DIAGNOSTICS
Product Code: JLW
PMA / PMN Number: K961491
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. DIFFERENCES IN RESULTS FROM ASSAY FROM DIFFERENT MANUFACTURERS CAN BE DUE TO THE DIFFERENT SETUPS OF THE ASSAYS, DIFFERENT ANTIBODIES USED, AND DIFFERENCE IN STANDARDIZATION MATERIALS AND METHODOLOGIES USED.

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 FROM COBAS E 801 MODULE 1611-01. THE SAMPLE WAS REPEATED ON A SIEMENS ANALYZER. THE INITIAL ELECSYS FT4 II ASSAY RESULT WAS 28.1 PMOL/L AND REPEAT RESULT WAS 16.1 PMOL/L. THE INITIAL ELECSYS TSH ASSAY RESULT WAS 1.28 MIU/L AND THE REPEAT RESULT WAS 2.56 MIU/L. THE INITIAL ELECSYS FT3 RESULT WAS 12.2 PMOL/L AND THE REPEAT RESULT WAS 4.7 PMOL/L. THIS MEDWATCH IS FOR THE TSH ASSAY. REFER TO THE "MEDWATCHS" WITH PATIENT IDENTIFIERS (B)(6) AND (B)(6) FOR THE OTHER ASSAYS INVOLVED. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1008263	ELECSYS TSH ASSAY	RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE	JLW	ROCHE DIAGNOSTICS	NA	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	37 YR			PROPANOLOL\| VALIUM\| ZYPREXA