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 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The initial reporter received a questionable elecsys tsh assay result for one patient from the cobas 8000 e 801 module, serial number (b)(4) compared to an architect result.This medwatch covers the alleged results for tsh.Please refer to medwatch mdr-44754 for the alleged ft3 assay results.The results were reported outside of the laboratory to a physician.The architect result was believed to be correct as the patient does not have a thyroid tumor or hyperthyroidism symptoms.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.No general product problem could be found.

Manufacturer Narrative

Upon further investigation of the patient sample, a streptavidin interferent against a component of the reagent was confirmed.This interference is covered in product labeling: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." a general product problem could be excluded.

• 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: 10138712
• MDR Text Key: 203324682
• Report Number: 1823260-2020-01411
• 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,Followup
• Report Date: 10/23/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2020
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 05/15/2020; 05/15/2020
• Supplement Dates FDA Received: 07/07/2020; 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1