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 09/15/2020

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 one patient tested on a cobas 8000 e 801 module serial number (b)(4).The patient¿s initial tsh result was reported outside the laboratory, and the physician questioned the result.The customer provided the patient¿s sample for investigation, and the patient¿s sample was tested on an abbott architect and a cobas 8000 e 801 module.

Manufacturer Narrative

The customer's calibration and qc data were requested but not provided.The patient's sample was provided for an investigation.The investigation reproduced the customer's tsh result.Upon further investigation of the sample, an interfering factor against a component of the reagent was not detected.Further clarification of the observed discrepancy for the tsh assay is not possible with available methods and the current state of the art.Product labeling states, "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 10698423
• MDR Text Key: 213690110
• Report Number: 1823260-2020-02586
• 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: 12/03/2020

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: 08443432190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR