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 10/15/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys anti-tshr on a cobas 6000 e601 module.No questionable results were reported outside of the laboratory.The sample initially resulted in an anti-tshr value of > 40.00 iu/l with a data flag.The result did not match the patient's clinical diagnosis and the sample was repeated.The repeat result was 1.45 iu/l.

Manufacturer Narrative

The serial number of the e601 analyzer is (b)(6).The pinch tubing was replaced.A probe was checked and it was ok.Precision studies were performed.The investigation is ongoing.

Manufacturer Narrative

Quality controls were within range.The investigation determined the replacement of the pinch tubing resolved the issue.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18067006
• MDR Text Key: 327308455
• Report Number: 1823260-2023-03514
• Device Sequence Number: 1
• Product Code: JZO
• UDI-Device Identifier: 07613336160305
• UDI-Public: 07613336160305
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08496609190
• Device Lot Number: 654109
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1