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

Catalog Number ASKU

Device Problem Low Test Results (2458)

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

Event Date 01/22/2018

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 tested for elecsys ft3 iii (ft3), the elecsys ft4 ii assay (ft4), and the elecsys tsh assay (tsh).No erroneous results were reported outside of the laboratory.Refer to the following medwatch a1.Patient identifiers for information related to each involved reagent: pt-(b)(6) = ft3, pt-(b)(6) = ft4, pt-(b)(6) = tsh.It was asked, but it is not known if all measurements were performed with the same sample.The roche ft3 measurement was performed on the customer's cobas 6000 e 601 module (e601).The roche tsh and ft4 measurements were performed on an unknown roche analyzer at another laboratory.The results of the roche measurements were too low compared to values measured with the delfia and siemens immulite methods.No adverse events were alleged to have occurred with the patient.

Manufacturer Narrative

A sample from the patient was not available for investigation.The investigation was unable to find a definitive root cause.From the provided information, a general reagent issue can most likely be excluded.

• 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: 7286010
• MDR Text Key: 100900463
• Report Number: 1823260-2018-00536
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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,Followup
• Report Date: 03/07/2018

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 01/24/2018
• Supplement Dates FDA Received: 03/07/2018
• 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
• Patient Age: 24 MO