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

Catalog Number 07026951190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of questionable elecsys tsh assay results tested on a cobas 8000 e 602 module and elecsys ft4 iii assay, elecsys ft3 iii, and elecsys anti-tshr immunoassay results tested on a cobas 8000 e 801 module for 1 patient sample compared to competitor methods.The e 801 serial number was (b)(4).The e 602 serial number was not provided.This medwatch will cover anti-tshr.Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii results, medwatch with patient identifier (b)(6) for information on the ft3 iii results, and medwatch with patient identifier (b)(6) for information on the tsh results.The tsh result was 0.18 iu/l on the e 602 and 1.62 iu/l on the beckman dxi access.The ft4 iii result was >100 pmol/l on the e 801 and 16.73 pmol/l on the siemens centaur.The ft3 iii result was 17.1 pmol/l on the e 801 and 4.915 pmol/l on the siemens centaur.The anti-tshr result was >40 iu/l on the e 801 and <0.9 iu/l on the thermo fisher brahms kryptor.The results from the e 801 and the e 602 were reported outside of the laboratory and the physician questioned the results.There was no adverse event.

Manufacturer Narrative

The customer sent the patient sample to the manufacturer for investigation.The customer's ft3, ft4, tsh, and anti-tshr results were reproduced.The presence of an interfering factor was detected in the sample.This interference is documented in product labeling for the assay.The investigation did not identify a product problem.

• 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: 8429153
• MDR Text Key: 139102520
• Report Number: 1823260-2019-01123
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 07026951190
• Device Lot Number: 35935501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2019
• 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