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

Catalog Number 08443432190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Output Problem (3005)

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

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The patient sample was requested for investigation.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys tsh assay results for 1 patient sample on a cobas e 801 analytical unit compared to an abbott architect analyzer.Refer to the attachment to the medwatch for all patient data.

Manufacturer Narrative

The qc recovery data provided was acceptable.Based on the available data, a general reagent issue could be excluded.The investigation did not identify a product problem.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18340406
• MDR Text Key: 331053499
• Report Number: 1823260-2023-04056
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 07613336157633
• UDI-Public: 07613336157633
• Combination Product (y/n): Y
• Reporter Country Code: TH
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08443432190
• Device Lot Number: 70629800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• 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
• Treatment: CARBOPLATIN.; ETHAMBUTOL.; ISONIAZID.; PYRAZINAMIDE.; RIFAMPIN.