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

Catalog Number 06437281190

Device Problem Low Test Results (2458)

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

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of questionable low results for 3 patient samples tested for elecsys tsh assay (tsh), elecsys t3 (t3), and elecsys ft4 ii assay (ft4 ii) tested on a cobas 6000 e 601 module.Medwatches for this event include those.Patient identifiers = (b)(6).Please refer to the attachment to this medwatch for relevant data.Discrepant results are highlighted.It was unknown if the erroneous results were released outside of the laboratory.There was no allegation of an adverse event.The samples were manually poured over into the sample tubes to ensure that there was no foam or bubbles present.The cobas e601 serial number was not provided.The investigation is currently ongoing.

Manufacturer Narrative

The normal reference for ft4ii is 12 - 22 pmol/l.Further investigation stated that a general reagent issues can be excluded for ft4 ii based on the calibration and qc results provided.

Manufacturer Narrative

The investigation was unable to find 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
• MDR Report Key: 7425515
• MDR Text Key: 105917370
• Report Number: 1823260-2018-01139
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K961489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2018

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 Expiration Date: 11/30/2018
• Device Catalogue Number: 06437281190
• Device Lot Number: 27034101
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 03/29/2018; 03/29/2018
• Supplement Dates FDA Received: 04/17/2018; 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1