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 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they received erroneous results for one patient sample tested with elecsys ft3 iii, the elecsys ft4 iii assay, the elecsys ft4 ii assay, the elecsys anti-tshr immunoassay, and roche diagnostics cobas elecsys anti-tpo on a cobas 8000 e 801 module.The erroneous 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 anti-tpo assay, and refer to the medwatch with patient identifier (b)(6) for information related to the ft4 ii assay.The sample was initially tested at the customer site on the e 801 analyzer on (b)(6) 2019.The sample was also repeated for ft3, ft4, and anti-tpo using the abbott method.The sample was repeated for anti-tshr using the yamasa method.The sample was provided for investigation, where it was tested on a second e 801 analyzer on (b)(6) 2019.No adverse events were alleged to have occurred with the patient.The serial number of the e 801 analyzer used at the customer site was asked for, but not provided.The serial number of the e 801 analyzer used for investigation is (b)(4).Based on the provided information, a general reagent issue can most likely be excluded.The investigation could not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

Evaluation method codes have been updated.

• 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: 8425662
• MDR Text Key: 138968890
• Report Number: 1823260-2019-01090
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07026951190
• Device Lot Number: 359355
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2019
• 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
• Patient Age: 25 YR