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

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received an erroneous result for one patient sample tested for free thyroxine (ft4) on an e601 analyzer.It was asked, but it is not known if an erroneous result was reported outside of the laboratory.The patient was born in (b)(6).The sample initially resulted as 27.0 pmol/l for ft4 when tested on the e601 analyzer.The sample was repeated with an ria test and the value was within the normal reference range for ft4.A specific repeat value was not provided.The patient was not adversely affected.The e601 analyzer serial number was asked for, but not provided.The patient sample was provided for investigation.The customer's high ft4 result could be reproduced.No interfering factors were detected within the sample.The biotin concentration of the sample was measured and it was determined that an influence of biotin on the ft4 value can most likely be excluded.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.A general reagent issue can most likely be excluded.For diagnostic purposes, the patient results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.

• 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: 5825599
• MDR Text Key: 50530413
• Report Number: 1823260-2016-01076
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Type of Report: Initial,Followup
• Report Date: 08/01/2016

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 Catalogue Number: 06437281190
• Device Lot Number: 140865
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 07/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/01/2016
• 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
• Patient Age: 40 YR