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

Model Number TSH

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2020

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, elecsys ft4 iii assay, and elecsys ft3 iii results for one patient tested on a cobas 8000 e 602 module serial number (b)(4).The customer reported out the results to a physician who asked for the re-measurement of the sample.The patient¿s sample was provided for an investigation and was tested on a cobas 8000 e 602 module.Also, the patient's sample was outsourced and tested on an abbott architect analyzer and siemens centaur analyzer.Refer to the attachment on the medwatch for all patient data.This medwatch is for tsh.Refer to the medwatch with a1 patient identifier (b)(4) for the ft4 assay and (b)(4) for the ft3 assay.

Manufacturer Narrative

The customer's calibration and qc data were requested but not provided.The customer provided a patient's sample for investigation.The investigation confirmed the customer's tsh results.Upon investigation of the patient sample, an interferent against a component of the reagent was confirmed, streptavidin.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.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.

• 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: 10844305
• MDR Text Key: 227502481
• Report Number: 1823260-2020-02909
• 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: 12/29/2020

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: 11731459122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1