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

Model Number TSH

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

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

Event Date 08/10/2022

Event Type  malfunction  

Manufacturer Narrative

The sample was requested for investigation.

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys t3 (t3), elecsys ft3 (ft3), elecsys t4 (t4), elecsys ft4 (ft4) and elecsys tsh (tsh) on a cobas 8000 e 602 module compared to the siemens and autobio methods.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(6) for information on the t3 results, medwatch with patient identifier (b)(6) for information on the ft3 results, medwatch with patient identifier (b)(6) for information on the ft4 results and medwatch with patient identifier (b)(6) for information on the t4 results.Refer to the attached data for the patient results.The roche results were reported outside of the laboratory where they were questioned as they did not correspond to the patient¿s clinical picture.The sample was repeated by 2 other methods.The customer suspects an interference affecting the roche results.The e602 module serial number was (b)(4).

Manufacturer Narrative

The reagent material number was provided by the investigation.Section d4, catalog number, and udi# were updated.Section g4, 510k was updated.The sample was submitted for investigation.The customer's results were reproduced during the investigation.Interference testing was performed and no interfering factors were identified.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TSH
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15349993
• MDR Text Key: 305687635
• Report Number: 1823260-2022-02713
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K961491
• 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: 10/06/2022

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 Model Number: TSH
• Device Catalogue Number: 08429324190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 09/12/2022
• Supplement Dates FDA Received: 10/06/2022
• 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