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 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).

Event Description

The initial reporter complained of questionable thyroid results from a cobas 8000 e 801 module compared to both a wako accuraseed instrument and an abbott architect instrument.From the data provided, the elecsys tsh assay and elecsys ft4 iii assay data was a reportable malfunction.This medwatch will cover tsh.For information on ft4 iii refer to the medwatch with patient identifier (b)(6).It was unknown if the erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The customer's cobas e801 serial number was (b)(4).Calibration and qc data from the investigation site was acceptable.The serial number for the cobs e801 used at the investigation site was (b)(4).The tsh reagent lot used on this instrument was 365417 with an expiration date of feb-2020.The ft4 iii reagent lot used on this instrument was 380330 with an expiration date of dec-2019.The investigation determined that a general reagent issue can most likely be excluded.For the differences of the tsh and ft4 values generated with the different types of analyzers: it needs to be taken into account that 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.

• 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: 8550379
• MDR Text Key: 143412446
• Report Number: 1823260-2019-01585
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TSH
• Device Catalogue Number: 07028091190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2019
• 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