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

Catalog Number 06437281190

Device Problem High Test Results (2457)

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

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of erroneous results for 2 patient samples tested for elecsys tsh assay (tsh), elecsys ft4 ii assay (ft4 ii) and elecsys ft3 iii (ft3 iii) on a cobas 8000 e 602 module compared to the architect method.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the tsh erroneous results and medwatch with patient identifier (b)(6) for information on the ft3 iii erroneous results.There was no allegation that an adverse event occurred.The e602 module serial number was not provided.

Manufacturer Narrative

The 2 patient samples were submitted for investigation and tested on a cobas 8000 e 602 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site.Erroneous results were generated for tsh, ft4 ii and ft3 iii.The e602 module serial number used at the investigation site was either (b)(4).The e411 analyzer serial number used at the investigation site was (b)(4).The ft4 ii reagent lot number used at the investigation site was 246825 with an expiration date of 30-jun-2018.A specific root cause was not identified.There was not enough sample volume left to complete the investigation.For both patient samples, the ft3 iii and ft4 ii results at the customer site and the e602 module at the investigation site were above the normal reference range.The ft3 iii and ft4 ii results from the e411 analyzer at the investigation site were within the normal reference range.Notable differences were observed between the e411 analyzer and the e602 modules compared to the abbott method, however; since there was not enough sample remaining, the root cause for this discrepancy cannot be determined.(b)(4).

• 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: 6856067
• MDR Text Key: 85924920
• Report Number: 1823260-2017-01952
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2017

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: 08/21/2017
• Initial Date FDA Received: 09/11/2017
• Supplement Dates Manufacturer Received: 08/21/2017
• Supplement Dates FDA Received: 10/06/2017
• 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