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 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for two patient samples tested for the elecsys tsh assay (tsh), elecsys ft3 iii (ft3), the elecsys ft4 ii assay (ft4), and the elecsys anti-tshr immunoassay (anti-tshr) on a cobas 8000 e 801 module (e801).The erroneous results were reported outside of the laboratory.The patients' endocrine doctor stated that the he suspected high tsh results for the samples.Please refer to the medwatches with the following patient identifiers for information related to all involved tests: (b)(6), the first patient sample was collected on (b)(6) 2017 and the second patient sample was collected on (b)(6) 2017.Both patient samples were tested on the e801 analyzer at the customer site on (b)(6) 2017.The samples were repeated on a centaur analyzer and the anti-tshr test for sample 1 was repeated using the yamasa test method.Both samples were provided for investigation where they were tested on a second e801 analyzer and a cobas e 411 immunoassay analyzer (e411).No adverse events were alleged to have occurred with the patients.The e801 analyzer used at the customer site was serial number (b)(4).The e801 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 265662, with an expiration date of november 2018 was used on this analyzer.The e411 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 265631, with an expiration date of september 2018 was used on this analyzer.A specific root cause could not be determined based on the provided information.There was not a sufficient amount of sample volume left for further investigation.A general reagent issue can most likely be excluded.A factor which interferes with one or more components of the assays from roche and /or siemens may be present in the samples of these patients.

• 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: 7215010
• MDR Text Key: 98069353
• Report Number: 1823260-2018-00205
• 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: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• 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
• Date Manufacturer Received: 01/09/2018
• 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