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	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys ca 19-9 and elecsys cea results from two patient samples tested on the cobas 6000 e601 module.This medwatch is for the elecsys ca 19-9 assay.Please refer to medwatch with a1.Patient identifier (b)(6) for the elecsys cea assay.On (b)(6) 2024: the initial result from the reported reagent lot was 459.90 u/ml.The first repeat result from a different elecsys ca19-9 reagent product was 28.82 u/ml.On (b)(6) 2024: the second repeat result from a new reagent pack of the same reported reagent lot was 26.52 u/ml.
Additional Manufacturer Narrative
The serial number of the cobas 6000 e601 module is (b)(6).The customer does not use the required tip/cup for the module.The measuring cells were overdue for replacement.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The issue was consistent with the customer's use of unapproved procell, cleancell, and tip/cups.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: 20846874
• Report Number: 1823260-2024-03523
• Device Sequence Number: 3771344
• 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): 12/27/2024

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: 10/31/2025
• Device Catalogue Number: 11776193122
• Device Lot Number: 78239101
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 12/27/2024
• 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