MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TSH ELECSYS COBAS E 200 V2; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number TSH

Device Problem High Test Results (2457)

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

Event Date 06/22/2021

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tsh assay on two cobas e 411 immunoassay analyzers.The results measured on the e411 analyzers were reported outside of the laboratory to the medical doctor in charge.The doctor did not believe the values obtained on the e411 analyzers.The sample was tested repeatedly on an abbott architect analyzer, resulting in suppressed tsh values of 0.05 - 0.08 u/ml.The sample was also tested multiple times on two e 411 analyzers, resulting in normal tsh values around 2.6 uiu/ml.An additional tsh value of 2.65 uiu/ml from one of the two e411 analyzers was also provided.The serial number for one of the e411 analyzers was provided as (b)(4).The serial number of the second e411 analyzer was not provided.

Manufacturer Narrative

The patient sample was provided for investigation.Investigations of the sample determined it did not contain an interfering factor against a component of the tsh assay.The tsh value measured with the roche device was deemed correct.The investigation could not identify a product problem.

• Brand Name: TSH ELECSYS COBAS E 200 V2
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12188928
• MDR Text Key: 268341758
• Report Number: 1823260-2021-02076
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• PMA/PMN Number: K961491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

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
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1