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

Catalog Number 06437281190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable free thyroxine (ft4) and thyrotropin (tsh) results for one patient sample.Refer to the medwatch with patient identifier (b)(6) for the tsh assay.The results from the cobas 8000 e602 analyzer serial number (b)(4) were ft4 0.56 ng/dl and tsh 3.93 mui/l which were not reported outside the laboratory.The results from the abbott architect were ft4 0.73 ng/dl and tsh 2.95 mu/l which were reported outside the laboratory.It was unclear if these results were generated from the same patient sample.The patient was not adversely affected.

Manufacturer Narrative

A specific root cause could not be identified.Sample from the patient was submitted for investigation and the customer¿s results were reproduced.No interfering factor was identified in the sample.As the sample result seemed plausible, no reagent specific issue could be identified.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5213461
• MDR Text Key: 30858463
• Report Number: 1823260-2015-04496
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/05/2016

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: 03/30/2016
• Device Catalogue Number: 06437281190
• Device Lot Number: 18492700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 11/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2016
• 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
• Treatment: LORAZEPAM NORMON
• Patient Age: 039 YR