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

Catalog Number 06437281190

Device Problem Low Test Results (2458)

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

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(4).Unique identifier (udi)#: (b)(4), (b)(6).

Event Description

The customer stated that they received erroneous results for one patient sample tested for the elecsys ft4 ii assay (ft4) on a roche diagnostics elecsys e170 modular analytics immunoassay analyzer (e170).An erroneous result was reported outside of the laboratory to a physician.Refer to the attachment for all patient data.The sample was initially tested on the customer's e170 analyzer.The sample was repeated on a centaur analyzer.The sample was also provided for investigation, where it was tested on a cobas 6000 e 601 module (e601) analyzer on (b)(6) 2018.No adverse events were alleged to have occurred with the patient.The serial number of the customer's e170 analyzer was asked for, but not provided.The e601 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 225150, with an expiration date of april 2018 was used on this analyzer.Based on the provided information, a general reagent issue could most likely be excluded.The investigation was unable to find a definitive root cause.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• 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: 7515043
• MDR Text Key: 108368061
• Report Number: 1823260-2018-01506
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/15/2018

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: 06437281190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/15/2018
• 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