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

Catalog Number 07027397190

Device Problem Low Test Results (2458)

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

Event Date 03/31/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for one patient sample tested for elecsys ft3 iii (ft3) and the elecsys ft4 ii assay (ft4) on a cobas 8000 e 801 module (e801).It was asked, but it is not known if any erroneous results were reported outside of the laboratory.Please refer to the medwatches with the following patient identifiers for information related to each affected assay: (b)(6) = ft3.(b)(6) = ft4.Refer to the attachment for all patient data.The sample was initially tested on the customer's e801 analyzer.The sample was also tested on a siemens centaur analyzer.The sample was provided for investigation, where it was tested on a second e801 analyzer, a cobas 6000 e 601 module (e601), and a cobas e 411 immunoassay analyzer (e411).No adverse events were alleged to have occurred with the patient.The serial number of the e801 analyzer used by the customer was asked for, but not provided.The e801 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 225159, with an expiration date of 31-may-2018 was used on this analyzer.The e601 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 288197, with an expiration date of 31-dec-2018 was used on this analyzer.The e411 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 288197, with an expiration date of 31-dec-2018 was used on this analyzer.Based on the provided data, a general reagent issue could most likely be excluded.The remaining sample volume was not sufficient enough for further investigation.The investigation was unable to find a definitive root cause.

• Brand Name: ELECSYS FT4 II ASSAY
• 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: 7472297
• MDR Text Key: 107563601
• Report Number: 1823260-2018-01302
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131244
• 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: 04/30/2018

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: 07027397190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 04/30/2018
• 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