MAUDE Adverse Event Report: ROCHE DIAGNOSTICS T4; RADIOIMMUNOASSAY, TOTAL THYROXINE

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The sample was submitted for investigation.Investigation confirmed the presence of a streptavidin interfering factor.This specific interference is addressed in product labeling.

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient sample tested for free thyroxine (ft4).Of the data provided, erroneous thyrotropin (tsh), free triiodothyronine (ft3), thyroxine (t4), and triiodothyronine (t3) were also identified.The erroneous results were reported outside of the laboratory.This medwatch will cover t4.Refer to medwatch with (b)(6) for information on the ft4 erroneous results, medwatch with (b)(6) for information on the tsh erroneous results, medwatch with (b)(6) for information on the ft3 erroneous results, and medwatch with (b)(6) for information on the t3 erroneous results.Based on the ft4 results, it was suspected that the patient had hyperthyroidism and was prescribed anti-thyroid medications of propylthiouracil and thiamazole for 2 consecutive days.No adverse event occurred due to this treatment.The e601 analyzer used at the customer site was (b)(4).

• Brand Name: T4
• Type of Device: RADIOIMMUNOASSAY, TOTAL THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5024940
• MDR Text Key: 24306592
• Report Number: 1823260-2015-04012
• Device Sequence Number: 1
• Product Code: CDX
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: ASKU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• 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: 0182845
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 023 YR