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

Model Number TSH

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The e801 module used at the investigation site was (b)(4).The tsh reagent lot number used at the investigation site was 386646 with an expiration date of may-2020.Calibration and qc at the investigation site were acceptable.The sample was requested for investigation but could not be provided.Since the sample could not be provided, the investigation could not be completed.From the data provided, a general reagent issue can be excluded.Assays from different manufacturers, in this case abbott, can generate different results.This relates to the overall setup of the assays, the antibodies used and differences in reference materials and standardization methodology.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys tsh (tsh) and elecsys ft3 iii (ft3 iii) on a cobas e 801 module compared to the accuraseed method.It is not known if any questionable results were reported outside of the laboratory.The sample was submitted for investigation where discrepant results were identified for elecsys ft4 iii (ft4 iii) between the e801 module used at the investigation site and the architect method, discrepant tsh results were identified between the customer's e801 module and the e801 module at the investigation site and discrepant ft3 iii results were identified between the customer's e801 module, the architect method and the e801 module used at the investigation site.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results and medwatch with patient identifier (b)(6) for information on the ft4 iii results.There was no allegation that an adverse event occurred.The customer's e801 module serial number was (b)(4).

• 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: 8735846
• MDR Text Key: 149380879
• Report Number: 1823260-2019-02324
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• 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: 06/07/2019
• 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
• Patient Age: 33 YR