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

Catalog Number 06437281190

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer questioned results for 2 patient samples tested for elecsys tsh assay (tsh), elecsys ft4 ii assay (ft4 ii) and elecsys ft3 on a cobas 8000 e 602 module.The customer reported the results outside of the laboratory and requested an investigation of the patient samples.The 2 patient samples were submitted for investigation where they were tested an a cobas e 801 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site.No discrepant results were identified between the customer's e602 module, the e801 module or the e411 analyzer.The 2 patient samples were sent to an external laboratory where they were tested by the architect method.Discrepant results were identified for tsh, ft4 ii, elecsys ft4 iii (ft4 iii) and ft3 between the customer's e602 module, the architect method, the e801 module used at the investigation site and the e411 analyzer used at the investigation site.Refer to the following related medwatches with patient identifiers: (b)(6).There was no allegation that an adverse event occurred.The serial number for the customer's e602 module was not provided.The e801 serial number was (b)(4).The e411 analyzer serial number was (b)(4).The ft4 ii reagent lot number used at the investigation site was 303235 with an expiration date of feb-2019.Calibration and qc at the investigation site were acceptable.There was not enough sample volume left to complete the investigation.Assays from different manufacturers can generate different results.Based on the information provided, a general reagent issue can be excluded.The investigation was unable to determine 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: 7678346
• MDR Text Key: 113751164
• Report Number: 1823260-2018-02230
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 04015630930920
• UDI-Public: 4015630930920
• 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: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• 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: 06/21/2018
• 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