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

Catalog Number 08496609190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 11/03/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for five patient samples tested with the elecsys anti-tshr immunoassay ver.2 on a cobas e 411 immunoassay analyzer.It was asked, but it is unknown if any incorrect results were reported outside of the laboratory.After noticing that all initial patient sample anti-tshr values were > 40.00 iu/l immediately after the analyzer switched to using a standby reagent pack, the customer ran controls and both controls recovered 40.00 iu/l.The next day, the customer opened a new reagent pack and performed control measurements on both reagent packs.Controls recovered within range.The samples were then repeated using the new reagent pack.The first sample initially resulted in anti-tshr values of > 40.00 iu/l with a data flag and < 0.800 iu/l with a data flag.The sample was repeated twice with the new reagent pack on (b)(6) 2022, resulting in values of < 0.800 iu/l with a data flag and < 0.800 iu/l with a data flag.The last value of < 0.800 iu/l with a data flag was reported outside of the laboratory.The second sample initially resulted in anti-tshr values of > 40.00 iu/l with a data flag and 2.58 iu/l with a data flag.The sample was repeated twice with the new reagent pack on (b)(6) 2022, resulting in values of < 0.800 iu/l with a data flag and < 0.800 iu/l with a data flag.The last value of < 0.800 iu/l with a data flag was reported outside of the laboratory.The third sample initially resulted in anti-tshr values of > 40.00 iu/l with a data flag and > 40.00 iu/l with a data flag.The sample was repeated twice with the new reagent pack on (b)(6) 2022, resulting in values of 1.37 iu/l and 1.40 iu/l.The last value of 1.40 iu/l was reported outside of the laboratory.The fourth sample initially resulted in anti-tshr values of > 40.00 iu/l with a data flag and 9.79 iu/l with a data flag.The sample was repeated twice with the new reagent pack on (b)(6) 2022, resulting in values of 5.40 iu/l with a data flag and 5.81 iu/l with a data flag.The last value of 5.81 iu/l with a data flag was reported outside of the laboratory.The fifth sample initially resulted in anti-tshr values of > 40.00 iu/l with a data flag and 1.06 iu/l.The sample was repeated twice with the new reagent pack on (b)(6) 2022, resulting in values of 1.16 iu/l and 1.12 iu/l.The last value of 1.12 iu/l was reported outside of the laboratory.The serial number of the e411 analyzer is (b)(4).

Manufacturer Narrative

Na.

Manufacturer Narrative

The issue is consistent with bubbles/foam in the reagent pack after reagent replacement.Each reagent pack must be controlled prior to use and this was not done by the customer.Product labeling states: "controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per reagent kit, and following each calibration.".

Manufacturer Narrative

The customer has confirmed that no incorrect results were reported outside of the laboratory.

• Brand Name: ELECSYS ANTI-TSHR
• Type of Device: THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15831359
• MDR Text Key: 307719503
• Report Number: 1823260-2022-03690
• Device Sequence Number: 1
• Product Code: JZO
• UDI-Device Identifier: 07613336160305
• UDI-Public: 07613336160305
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K193313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2022

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: 08/31/2023
• Device Catalogue Number: 08496609190
• Device Lot Number: 61765100
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/20/2022
• Supplement Dates Manufacturer Received: 12/06/2022; 12/20/2022
• Supplement Dates FDA Received: 12/09/2022; 12/29/2022
• 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
• Patient Sequence Number: 1