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

Model Number	CA 19-9
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The last calibration performed on 17-oct-2022 on e 601, serial number: (b)(4) had calibration signals below the expected range for calibrators 1 and 2.The calibration was done 14 weeks ago.Per product labeling: "renewed calibration is recommended as follows: after 12 weeks when using the same reagent lot." quality control results for control level 1 were not provided.Quality results for control level 2 were within the specified range.The last exchange of the measuring cell was on 08-jun-2021.The investigation could not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys ca 19-9 assay on cobas 6000 e 601 modules.The sample was initially tested on e 601, serial number: (b)(4), resulting in an alarm message.The sample was repeated on a second e 601 (serial number: (b)(4) resulting in a ca 19-9 value of 1000 u/ml, accompanied by a data flag.The sample was repeated with a 1:10 dilution on the same analyzer, resulting in a value of 52.74 u/ml.This result was reported outside of the laboratory and questioned by the physician.The sample was then repeated twice on the initial analyzer, resulting in ca 19-9 values of 1000 u/ml, accompanied by a data flag and 9019 u/ml using a 1:10 dilution.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16419419
• Report Number: 1823260-2023-00539
• Device Sequence Number: 20178187
• Product Code: NIG
• UDI-Device Identifier: 04015630904297
• UDI-Public: 04015630904297
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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
• Report Date (Section B): 02/22/2023

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 Expiration Date: 02/29/2024
• Device Model Number: CA 19-9
• Device Catalogue Number: 11776193122
• Device Lot Number: 64362405
• 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: 01/25/2023
• Initial Report FDA Received Date: 02/22/2023
• 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