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

Catalog Number	07026935190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) performed repeatability testing for anti-tpo and confirmed there were no issues.
Additional Manufacturer Narrative
Calibration and qc were acceptable.No issues were identified during a review of the alarm trace data.Due to the limited information provided, the cause of the event could not be determined.The investigation did not identify a product problem.
Additional Manufacturer Narrative
The e801 module serial number is (b)(6).
Event or Problem Description
The initial reporter complained of a discrepant high result for 1 patient sample tested for elecsys anti-tpo (anti-tpo) on a cobas 8000 e 801 module.The initial result was 73.2 iu/ml.The sample was repeated twice with results of less than 9 iu/ml.The repeat results were believed to be correct as these matched the patient¿s previous anti-tpo results.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19041294
• Report Number: 1823260-2024-01035
• Device Sequence Number: 7270898
• Product Code: JZO
• UDI-Device Identifier: 04015630939626
• UDI-Public: 04015630939626
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 04/22/2024

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 Expiration Date: 06/30/2024
• Device Catalogue Number: 07026935190
• Device Lot Number: 750634
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 04/10/2024; 04/19/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/12/2024; 04/22/2024
• 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