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

Catalog Number 06437281160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2016

Event Type  malfunction  

Event Description

The customer stated that the thyroid panel results for two samples from the same patient tested on an e602 analyzer did not match results obtained from other vendor analyzers and did not match the diagnosis of the patient.The patient was originally seen at an initial site and was referred to the customer site due to abnormal test results without clinical symptoms.The results for the two samples from the customer site were said to match the results from the initial site.No results were provided from the initial site.The two samples had erroneous free thyroxine (ft4) and thyrotropin (tsh) results that are reportable as a malfunction.The erroneous results were not reported outside of the laboratory.This medwatch will refer to ft4.Please refer to the medwatch with patient identifier (b)(6) for information related to tsh.Please refer to the attachment for the results from the two samples.The samples were initially tested at the customer site on an e602 analyzer and correspond to the "roche" results on the attachment.The first sample was repeated on a beckman dxi analyzer (corresponding to "dxi" results on the attachment) and a siemens centaur analyzer (corresponding to "centaur" results on the attachment).The results from the centaur analyzer were believed to be correct since they match the patient diagnosis.The first sample was also treated with streptavidin agarose and a heterophile blocking tube (hbt) from scantabodies, then tested on the e602 analyzer.The agarose and hbt treated sample results correspond to the "roche agarose" and "roche hbt" results respectively in the attachment.The patient was not adversely affected.The e602 analyzer serial number was (b)(4).The customer declined a service visit and stated that he believes the issue to be sample related.

Manufacturer Narrative

The samples were provided for investigation.Investigations were not able to confirm the ft4 values generated at the customer site.It was determined that the sample contained a slight interference to the streptavidin used in the ft4 reagent.This limitation is covered in product labeling.

• Brand Name: FT4 II - 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: 5784808
• MDR Text Key: 49239383
• Report Number: 1823260-2016-00891
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

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: 10/31/2016
• Device Catalogue Number: 06437281160
• Device Lot Number: 18861000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/30/2016
• 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: 30 YR