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

Model Number TSH

Device Problem High Test Results (2457)

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

Event Date 12/04/2021

Event Type  malfunction  

Manufacturer Narrative

The customer treated the sample by polyethylene glycol (peg) and obtained a calculated tsh result of 44.0 uiu/ml on the e801 module.The customer performed a 1:10 dilution and obtained a calculated tsh result of 119 uiu/ml on the e801 module.The investigation is ongoing.

Event Description

The initial reporter questioned high results not corresponding with the clinical picture for 1 patient tested for elecsys tsh (tsh) on a cobas e801 module.The result from the e801 module was 100 uiu/ml with a data flag.The result from the abbott method was 84.888 uiu/ml.The patient had no signs or symptoms of a thyroid dysfunction.The questionable results were reported outside of the laboratory.The e801 module serial number was (b)(4).

Manufacturer Narrative

Based on the information provided, 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13094364
• MDR Text Key: 288802887
• Report Number: 1823260-2021-03888
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 07613336157633
• UDI-Public: 07613336157633
• 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: 02/23/2022

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: 12/31/2022
• Device Model Number: TSH
• Device Catalogue Number: 08443432190
• Device Lot Number: 56833901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 01/31/2022
• Supplement Dates FDA Received: 02/23/2022
• 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
• Treatment: BEVACIZUMAB
• Patient Age: 32 YR
• Patient Sex: Male