MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR; ANTI-TSHR IMMUNOASSAY

Catalog Number 04388780190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of elevated thyroid panel results for 1 patient that did not match the clinical picture for this patient.Based on the data provided, the results for antibodies to tsh receptor (anti-tshr) from an e411 analyzer and antibodies to thyroid peroxidase (anti-tpo) from an e601 analyzer were erroneous and reported outside of the laboratory.This medwatch will cover anti-tshr.Refer to medwatch with patient identifier (b)(6) for information on the anti-tpo erroneous results.The anti-tshr result from the e411 analyzer was 2.74 iu/l and the anti-tpo result from the e601 analyzer was 72 iu/ml.Both results were reported to the clinician who indicated the results did not match the clinical picture for the patient.The clinician requested repeat testing at an external laboratory for t3 and t4 using the ria method.The t3 result was 106 ng/dl and the t4 result was 8.6 ug/dl which matched the clinical picture of the patient much better.No adverse event occurred.The e601 analyzer serial number was not provided.The e411 analyzer serial number was (b)(4).The customer thinks there is an interference in the sample.

Manufacturer Narrative

The patient sample was submitted for investigation.Investigation confirmed the presence of a streptavidin interfering factor.This interference most likely caused the erroneous anti-tshr result.This specific interference is addressed in product labeling.For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings.

• Brand Name: ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR
• Type of Device: ANTI-TSHR IMMUNOASSAY
• 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: 5682032
• MDR Text Key: 46001791
• Report Number: 1823260-2016-00690
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K080092
• 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: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04388780190
• Device Lot Number: 125679
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2016
• 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