MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TSH ELECSYS COBAS E 200 V2; 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 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The initial reporter received questionable tsh elecsys cobas e 200 v2, elecsys ft3 iii, and elecsys ft4 iii assay results for 1 patient sample on a cobas 8000 e 602 module, serial number (b)(4).This medwatch covers the tsh patient results.Refer to medwatch with a1 patient identifier (b)(6) for information regarding ft4 iii results and medwatch with a1 patient identifier (b)(6) for information regarding ft3 iii results.The results were reported outside of the laboratory.

Manufacturer Narrative

The patient sample was returned for investigation.The results indicate the presence of a sa (streptavidin) interference.The rarely occurring event of this interfering factor is covered by a disclaimer in the section limitation ¿ interference in the method sheets of all applicable products: "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: 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: 11367240
• MDR Text Key: 238618713
• Report Number: 1823260-2021-00546
• 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: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• 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
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1