MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number TSH

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2019

Event Type  malfunction  

Manufacturer Narrative

The calibration and qc data from the investigation site was acceptable.From the information provided and the analysis thereof, a general reagent issue most likely can be excluded.To the differences of the tsh and ft4 values generated with the different types of analyzers: assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter complained of a questionable elecsys ft4 iii assay result for 1 patient tested on a cobas 8000 e 801 module compared to a lumipulse.Upon further testing of the patient's sample at an investigation site, the elecsys tsh assay data from the investigation site's cobas 8000 e801 compared to the customer's limipulse result is a reportable malfunction.Refer to the medwatch with patient identifier (b)(6) for information on ft4 iii.The result in question was reported outside of the laboratory.There was no allegation of an adverse event.The cobas e801 serial number used at the customer's site is (b)(4).The cobas e801 serial number from the investigation site is (b)(4).The tsh reagent lot used on this analyzer is lot 386646 expiration may-2020.

• Brand Name: ELECSYS TSH ASSAY
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 8788419
• MDR Text Key: 150974898
• Report Number: 1823260-2019-02582
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: TSH
• Device Catalogue Number: 07028091190
• Device Lot Number: 386646
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: THYRADIN
• Patient Age: 43 YR