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

Catalog Number	07026951190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer stated that they received questionable results when testing 2 patient samples with the new elecsys anti-tshr immunoassay (anti-tshr) reagent lot number 322386 on a cobas 8000 e 801 module (e801).Of the two samples, one had an erroneous anti-tshr result.It was asked, but it is not known if an erroneous result was reported outside of the laboratory.The sample initially resulted with an anti-tshr value of 1.9 iu/l using old lot 283564.The sample was repeated twice with new reagent lot number 322386, resulting as 1.32 iu/l and 1.35 iu/l.No adverse events were alleged to have occurred with the patient.The serial number of the e801 analyzer was asked for, but not provided.
Additional Manufacturer Narrative
The customer provided two patient samples for investigation.The sample results could not be reproduced.From the information and data provided, a general reagent issue most likely can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR
• Common Device Name: ANTI-TSHR IMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7713447
• Report Number: 1823260-2018-02449
• Device Sequence Number: 19058377
• Product Code: JZO
• UDI-Device Identifier: 04015630939954
• UDI-Public: 4015630939954
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 07026951190
• Device Lot Number: 322386
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1