MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TG II; THYROGLOBULIN TEST SYSTEM

Catalog Number	08906564190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys tg ii on a cobas e 801 module.The sample initially resulted in a tg value of 1.09 ng/ml and repeated as 0.0400 ng/ml.The sample was repeated four times on (b)(6) 2024, resulting in tg values of 0.0447 ng/ml, 0.509 ng/ml, 0.493 ng/ml, and 0.499 ng/ml.The sample was repeated three times on (b)(6) 2024, each time resulting in tg values of 0.0400 ng/ml.
Additional Manufacturer Narrative
Upon review of alarm data, various sample quality related alarms were observed, including sample foam, sample clot, and sample short alarms.These alarms indicate a sample handling issue.A general reagent problem can be excluded based on the provided data.At the time of the event, the measuring cells were overdue for replacement.The measuring cells were replaced on (b)(6) 2024.The investigation determined the issue is consistent with insufficient analyzer maintenance and insufficient sample handling.

• Brand Name: ELECSYS TG II
• Common Device Name: THYROGLOBULIN TEST SYSTEM
• 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: 20158790
• Report Number: 1823260-2024-02587
• Device Sequence Number: 15545882
• Product Code: MSW
• UDI-Device Identifier: 07613336169582
• UDI-Public: 07613336169582
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K221890
• 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): 10/07/2024

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 Catalogue Number: 08906564190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 56 YR
• Patient Sex: Female