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

Catalog Number	07028091190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).(b)(6).
Event or Problem Description
The customer stated that they received erroneous results for one patient sample tested with the elecsys tsh assay, elecsys ft3 iii, the elecsys ft4 iii assay, and roche diagnostics cobas elecsys anti-tpo on a cobas 8000 e 801 module.The sample also had an erroneous result for the elecsys ft4 ii assay when tested on a second e 801 analyzer used for investigation.This medwatch will apply to the tsh assay.Please refer to the medwatches with the following.Patient identifiers for information related to each other affected assay: (b)(6) = ft3; (b)(6) = ft4 iii; (b)(6) = anti-tpo; (b)(6) = ft4 ii.Refer to the attachment for all patient data.The sample was tested on the customer's e 801 analyzer, then tested on abbott architect analyzers at the customer site and another laboratory.The sample was provided for investigation where it was tested on a second e 801 analyzer.Measurements for tsh, ft3, and ft4 iii were performed on the e 801 analyzer used for investigation on (b)(6) 2018.Measurements for ft4 ii and anti-tpo were performed on the e 801 analyzer used for investigation on (b)(6) 2018.No adverse events were alleged to have occurred with the patient.The e 801 analyzer used at the customer site is serial number (b)(4).The e 801 analyzer used for investigation is serial number (b)(4).Tsh reagent lot number 331814, with an expiration date of august 2019 was used on this analyzer.
Additional Manufacturer Narrative
A sample was investigated by the manufacturer.The sample contained an interferent to a component of the reagent.This is covered in product labeling.The package insert states: 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.

• Brand Name: ELECSYS TSH ASSAY
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8032766
• Report Number: 1823260-2018-04043
• Device Sequence Number: 1303143
• Product Code: JLW
• UDI-Device Identifier: 04015630939831
• UDI-Public: 4015630939831
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K961491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 07028091190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR