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

Model Number TSH

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

This investigation is ongoing.This event occurred in (b)(6).Unique identifier (udi) #: (b)(4).

Event Description

The initial reporter received questionable elecsys t-uptake assay and elecsys tsh assay results for one patient with the cobas 6000 e 601 module serial number (b)(4).This medwatch is for tsh assay.Refer to the medwatch with patient identifier (b)(6) for the t-uptake assay.The initial tsh result was 3.49 uiu/ml.The repeated result was 3.55 uiu/ml.The customer had the calculated free thyroxine index questioned by the doctor and a re-measurement was requested.On (b)(6) 2021, a second sample was sent for testing.The tsh result was 2.37 uiu/ml.It is unknown which result is deemed correct.

Manufacturer Narrative

The patient's sample was requested for an investigation, but the sample was not available.Based on the available data, the investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 11903409
• MDR Text Key: 270409934
• Report Number: 1823260-2021-01601
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 07/09/2021

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 05/28/2021
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR