MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I CA 19-9XR REAGENT KIT; SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER

Model Number	08P3221
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated alinity i ca 19-9xr result for an 83-year-old female patient who undergoes regular testing every six months or so.Due to the elevated alinity i ca 19-9xr result, the follow-up testing period was reduced, and the patient was tested again on (b)(6) 2023 which showed a lower result.It is unknown if the patient was diagnosed with pancreatic cancer.The following data was provided: ca 19-9xr result (2 months prior) = 90 u/ml.Follow-up result = (b)(6) 2023 ca 19-9xr result = 17 u/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, ticket trending review, device history record review, and labeling review.An in-house testing of retained reagent kit was also completed.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with the alinity i ca 19-9xr reagent and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Accuracy testing was also performed to evaluate the performance of alinity i ca19-9xr assay.Since the likely cause lot is unknown, a representative lot was selected for the testing.An internal ca 19-9xr panel was tested with retained kits of the representative lot.Acceptance criteria was met, which indicates acceptable product performance.Based on this investigation, no systemic issue or deficiency was identified for the alinity i ca 19-9xr assay, reagent lot unknown.
Event or Problem Description
The customer observed falsely elevated alinity i ca 19-9xr result for an(b)(6)female patient who undergoes regular testing every six months or so.Due to the elevated alinity i ca 19-9xr result, the follow-up testing period was reduced, and the patient was tested again on (b)(6)2023 which showed a lower result.It is unknown if the patient was diagnosed with pancreatic cancer.The following data was provided: ca 19-9xr result (2 months prior) = 90 u/ml follow-up result = 23may2023 ca 19-9xr result = 17 u/ml no impact to patient management was reported.

• Brand Name: ALINITY I CA 19-9XR REAGENT KIT
• Common Device Name: SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17244384
• Report Number: 3002809144-2023-00298
• Device Sequence Number: 4795577
• Product Code: NIG
• UDI-Device Identifier: 00380740155919
• UDI-Public: 00380740155919
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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 Model Number: 08P3221
• Device Catalogue Number: 08P32-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 07/02/2023
• Supplement Report FDA Received Date: 08/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Age: 83 YR
• Patient Sex: Female