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

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) - the patient was born in (b)(6).This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer questioned results for 1 patient sample tested for elecsys tsh assay (tsh), ft4, ft3, and anti-tpo on a cobas 6000 e 601 module.This medwatch will cover ft4.Refer to medwatch with patient identifier (b)(6) for information on the tsh results, medwatch with patient identifier (b)(6) for information on the ft3 results and medwatch with patient identifier (b)(6) for information on the anti-tpo results.The patient is being treated with qizenday and the customer suspected a biotin interference and sent the sample for testing by the abbott method where discrepant results were identified.Refer to attached data for the patient results.No erroneous results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The e601 module serial number was (b)(4).

Manufacturer Narrative

The patient sample was submitted for investigation.The customer's values were reproduced at the investigation site.During further investigation of the serum sample, a very high biotin concentration of approximately 750 ng/ml was detected.This concentration is far above the allowable threshold concentrations specified in product labeling of the respective assays: tsh: no interference up to 25 ng/ml, ft4: no interference up to 20 ng/ml, ft3: no interference up to 70 ng/ml, anti-tpo: no interference up to 10 ng/ml.This very high biotin concentration caused the low tsh results and the high ft4, ft3 and anti-tpo results.Product labeling states "samples should not be taken from patients receiving therapy with high biotin doses (i.E.> 5 mg/day) until at least 8 hours following the last biotin administration.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 ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7518706
• MDR Text Key: 109002370
• Report Number: 1823260-2018-01513
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: ASKU
• 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: 06/12/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 04/27/2018
• Supplement Dates FDA Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: QIZENDAY