MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-TPO; SYSTEM, TEST, THYROID AUTOANTIBODY

Catalog Number	07026935190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys anti-tpo results from one patient sample tested on the customer's cobas 6000 e601 module with serial number 29s7-07 and another hospital laboratory's e601 module with an unknown serial number.The initial result was reported outside of the laboratory.The reporter stated that the patient was hesitant about their condition, which prompted reruns of the initial patient sample.The patient sample was aliquoted into 3 parts and were tested in the customer's e 601, an autobio machine, a siemens machine, and another e 601.The reporter complained that a negative result was obtained from the elecsys anti-tpo assays, whereas positive results were obtained from the siemens and autobio assays.Please refer to the attachment pt-81257 for the highlighted questionable results.
Additional Manufacturer Narrative
The patient sample was requested for investigation.H3 other text : na.
Additional Manufacturer Narrative
The sample submitted for investigation was tested on a cobas e801 with the following results: anti-tpo: 18.6 iu/ml, anti-tg: 24.3 iu/ml.No interference was found in the sample.A general product problem could be excluded.

• Brand Name: ELECSYS ANTI-TPO
• Common Device Name: SYSTEM, TEST, THYROID AUTOANTIBODY
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16833683
• Report Number: 1823260-2023-01427
• Device Sequence Number: 11239531
• Product Code: JZO
• UDI-Device Identifier: 04015630939626
• UDI-Public: 04015630939626
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2023

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: 07026935190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown