MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 19-9; TEST, CARBOHYDRATE ANTIGEN (CA19-9)

Catalog Number	11776193122
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	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6000 e601 module serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys ca 19-9 results from the cobas 6000 e601 module.The initial result was 506.6 u/ml.The repeat results were 9.49 u/ml, 9.42 u/ml, and 9.52 u/ml.
Additional Manufacturer Narrative
The calibration and qc were within the specified ranges.The (b)(6) 2024 alarm trace had 10 records of alarm "abnormal sample aspiration" alarms.The investigation did not identify a product problem.The cause of the event could not be determined.A general reagent problem was not present, because the qc before the event was within ranges.

• Brand Name: ELECSYS CA 19-9
• Common Device Name: TEST, CARBOHYDRATE ANTIGEN (CA19-9)
• 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: 20785569
• Report Number: 1823260-2024-03447
• Device Sequence Number: 20085015
• Product Code: NIG
• UDI-Device Identifier: 04015630904297
• UDI-Public: 04015630904297
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050231
• 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): 12/30/2024

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: 06/30/2025
• Device Catalogue Number: 11776193122
• Device Lot Number: 75901403
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 12/25/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/30/2024
• 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 Sex: Unknown