MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T-UPTAKE ASSAY

Catalog Number 11731394122

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The initial reporter received questionable elecsys t-uptake assay and elecsys tsh assay results for one patient with the cobas 6000 e 601 module serial number (b)(4).This medwatch is for t-uptake assay.Refer to the medwatch with patient identifier (b)(6) for the tsh assay.The initial t-uptake result was 0.282.The repeated result was 0.31.The second repeated result was 0.200 with a data flag.The unit of measure was not provided.The customer had the calculated free thyroxine index questioned by the doctor and a re-measurement was requested.The customer centrifuged the test tube again, transfer the sample to a hitachi cup, and re-measured the t-uptake with a result of 0.200 with a data flag.On (b)(6) 2021, a second sample was sent for testing.The t-uptake result was 0.200 with a data flag.It is unknown which result is deemed correct.

Manufacturer Narrative

The calibration and qc data were acceptable.The patient's sample was requested for an investigation, but the sample was not available.Per 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." based on the available data, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS T-UPTAKE ASSAY
• Type of Device: NA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11903421
• MDR Text Key: 270410324
• Report Number: 1823260-2021-01600
• Device Sequence Number: 1
• Product Code: KHQ
• Combination Product (y/n): N
• PMA/PMN Number: K961488
• 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: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 11731394122
• Device Lot Number: 48911301
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR