MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 II ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number ASKU

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for five samples from the same patient tested for multiple assays on a cobas 6000 e 601 module (e601) analyzer.Affected assays include the elecsys ft4 ii assay (ft4ii), the elecsys ft4 iii assay (ft4iii), elecsys ft3 iii (ft3), the elecsys tsh assay (tsh), elecsys ferritin (ferr), roche diagnostics elecsys anti-tg (anti-tg), roche diagnostics cobas elecsys anti-tpo (anti-tpo), and the elecsys anti-tshr immunoassay (anti-tshr).Refer to the medwatches with the following patient identifiers for information related to each affected assay: (b)(6) = ft4ii; (b)(6) = ft4ii; (b)(6) = ft3; (b)(6) = tsh; (b)(6) = ferr; (b)(6) = anti-tg; (b)(6) = anti-tpo; (b)(6) = anti-tshr.The patient had "perfect" thyroid values in (b)(6) 2018.On(b)(6) 2018, the patient was hospitalized due to recurrent falling and general malaise.The 5 samples were collected from the patient and based on vastly increased ft4, ft3, and anti-tshr results, it was concluded that an initial attack of graves' disease occurred.The results for all thyroid assays did not fit the clinical picture of the patient, however, treatment for hyperthyroidism (strumasol) was started.Refer to attachment 1 for data from the five complained samples.Samples dated (b)(6) 2018 (sample 2), (b)(6) 2018 (sample 4), and (b)(6) 2018 (sample 5) were also tested on an abbott architect analyzer.In addition, the customer ran a comparison of the ft4ii and ft4iii assays on (b)(6) 2018 using samples dated (b)(6) 2018 (sample 1), (b)(6) 2018 (sample 2), and (b)(6) 2018 (sample 3).Unless otherwise indicated on attachment 1, the erroneous test results were reported outside of the laboratory.No adverse events were alleged to have occurred with the patient.The lot numbers and expiration dates of all involved reagents were asked for, but not provided.

Manufacturer Narrative

The customer has confirmed that tsi testing took place on a siemens immulite analyzer, not an abbott architect.Three samples from the patient were provided for investigation.Investigations of the samples determined that they contain an interfering factor which interferes with a component of the ft3, ft4ii, tsh, and ferr assays.The effect of this interfering factor is reduced with the ft4iii assay.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 FT4 II ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7560435
• MDR Text Key: 110053161
• Report Number: 1823260-2018-01696
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K131244
• 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: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR