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

Catalog Number 06437281160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The field application specialist reported the customer received questionable elecsys ft4 ii assay and elecsys tsh assay results for two samples for one patient and suspected biotin interference.The customer used cobas e 602 serial number (b)(4).This medwatch is for the ft4 assay results on (b)(6) 2016.Refer to the medwatch with patient identifier (b)(6) for the tsh assay.Refer to the medwatchs with patient identifiers (b)(6) for the results from another sample from the patient.The ft4 result for a sample drawn at 3:51 am was 1.9 ng/dl and the repeat result on a siemens centaur analyzer was 1.2 ng/dl.The repeat result was believed to be correct.The biotin consumption was (b)(6) 2016 at 8:28 am (10 mg provided as inpatient).The patient should have excreted the biotin at 12 hours, but the patient was in renal failure.The results were not reported outside the laboratory.The patient was not adversely affected.The customer refused a service visit.Sample from the patient was submitted for investigation and the customer's high ft4 result was reproduced.No interfering factor to streptavidin or other immunoglobulin that reacts with the reagent was found in the sample.

Manufacturer Narrative

The sample was tested further for free biotin concentrations and the result was approximately 209 ng/ml.This concentration was considerably above the allowable biotin concentration that is specified in product labeling for the assay.In addition, the patient also received furosemide.It is known that this drug causes elevated ft4 values if taken at the daily therapeutic dosage level.This information is documented in product labeling.Both the high level of biotin and the effect of the drug furosemide most likely had an impact on the ft4 assay values.From the provided information, a general reagent issue could 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: 6002476
• MDR Text Key: 56555581
• Report Number: 1823260-2016-01526
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 06437281160
• Device Lot Number: 14086200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2016
• 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: REFER TO THE ATTACHMENT TO THE MEDWATCH.
• Patient Age: 61 YR