MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-TSHR V2; THYROID AUTOANTIBODY TEST

Catalog Number 08496633190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi): (b)(4).The investigation is ongoing.

Event Description

The initial reporter had switched from version 1 to version 2 of the elecsys anti-tshr (anti-tshr) assay on a cobas e801 module and noted that the number of samples with results of <0.8 iu/l had decreased.The initial results from version 2 of the assay were reported outside of the laboratory where the physician requested additional testing.The customer performed a comparison between the different versions for 23 patient samples.Of this data, the results for 1 patient sample were discrepant.The customer is not sure which results are correct.The 23 patient samples were submitted for investigation where the results for 1 additional patient sample were discrepant.This medwatch will cover anti-tshr version 2.Refer to medwatch with a1 patient identifier pt-(b)(4) for information on the anti-tshr version 1 results.Refer to attached data for the results.The e801 module serial number at the customer site was (b)(4).The e801 module used at the investigation site was (b)(4).The reagent lots used were: anti-tshr v1 lot 485820 with an expiration date of nov-2021, anti-tshr v2 lot 473426 with an expiration date of aug-2021, and anti-tshr v2 lot 505102 with an expiration date of jan-2022.

Manufacturer Narrative

The initial report stated: "the e801 module serial number at the customer site was (b)(6) the cobas 8000 core unit serial number was (b)(6).The serial number for the e801 module used at the customer site was not provided.Calibration and qc were acceptable.Only the initial run at the customer site were slightly elevated; all the following repeat results were comparable.The cutoff used in japan is 2.0 iu/l, therefore, all results were below the cutoff leading to the same clinical interpretation of 'negative.' most of the results were between <0.8 iu/l and 1.1 iu/l, however, some single results were slightly higher.All samples were below or near the limit of quantification (loq) which explains the deviations.Based on the data provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS ANTI-TSHR V2
• Type of Device: THYROID AUTOANTIBODY TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11585992
• MDR Text Key: 245996784
• Report Number: 1823260-2021-00954
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• PMA/PMN Number: K193313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 08496633190
• Device Lot Number: 473426, 505102
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/29/2021
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1