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

Model Number ANTI-TSHR

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys ft3 iii, the elecsys ft4 iii assay, the elecsys tsh assay, and the elecsys anti-tshr immunoassay when tested on the customer's cobas 8000 e 801 module and a second e 801 module used for investigation.The sample also had discrepant results for the elecsys ft4 ii assay when tested on the e 801 module used for investigation.Incorrect results were reported outside of the laboratory.This medwatch will apply to the anti-tshr assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay, refer to the medwatch with patient identifier (b)(6) for information related to the ft4 iii assay, refer to the medwatch with patient identifier (b)(6) for information related to the ft4 ii assay, and refer to the medwatch with patient identifier (b)(6) for information related to the tsh assay.The sample was collected from the patient on (b)(6) 2019.The sample was tested on the customer's e 801 analyzer and with the wako accuraseed method on (b)(6) 2019.The sample was repeated for tsh, ft4, and ft3 using the architect method and repeated for anti-tshr using the yamasa method.The sample was provided for investigation where it was tested for tsh, ft3, ft4 iii, and ft4 ii on the second e 801 module on (b)(6) 2019.The sample was also tested for anti-tshr on the second e 801 module on (b)(6) 2019.The serial number of the customer's e 801 analyzer is (b)(4).The serial number of the e 801 analyzer used for investigation is (b)(4).Anti-tshr reagent lot number 408206, with an expiration date of june 2020 was used on this analyzer.

Manufacturer Narrative

The investigation determined the patient sample contained an interferent to the streptavidin component of the anti-tshr assay.This limitation is covered in product labeling.Per labeling: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.".

• 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
• MDR Report Key: 9213677
• MDR Text Key: 217165670
• Report Number: 1823260-2019-03788
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• PMA/PMN Number: K080092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

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 Model Number: ANTI-TSHR
• Device Catalogue Number: 07026951190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 10/01/2019
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1