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

Model Number TSH

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys tsh assay results for 1 patient sample on a cobas e 801 module, serial number (b)(4).This medwatch covers the alleged results for the tsh assay.Please refer to medwatch mdr (b)(4) for the alleged ft3 assay results.(b)(4).The results were reported to the patient's physician, who requested the sample test be repeated.

Manufacturer Narrative

The patient sample was returned for investigation.The customer's results were confirmed.The differences of the tsh values, generated with the different assays, relate to differences of the setups of the assays, the antibodies used and differences of the standardization materials and procedures used.The investigation did not identify a product problem.

• Brand Name: ELECSYS TSH ASSAY
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10614127
• MDR Text Key: 209414130
• Report Number: 1823260-2020-02411
• 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: 11/17/2020

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: 07028091190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 09/07/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR