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	02/08/2023
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated alinity i ca19-9 results for 1 patient with unknown medical history.The following results were provided (customer reference range 0-37 u/ml): initial result was > 96, 000u/ml.The customer redrew the patient and sent the sample to another laboratory, which generated a result of 21, 059 u/ml (method unknown).The customer re-tested the same sample that was tested on the initial analyzer (alinity i processing module) and generated a result of > 96, 000u/ml.There was no reported impact to patient management.
Event or Problem Description
Update: received additional information from customer on 27 mar 2023.Customer stated they performed a heterophile blocking tube test for the sample and generated the same result of > 96,000 u/ml.
Additional Manufacturer Narrative
The complaint investigation regarding a false elevated result of alinity i ca 19-9xr reagent lot 46236fp00, included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Device history record review did not identify any potential non conformances, non-conformances, or deviations for the associated reagent lot number 46236fp00 and complaint issue.The trending assessment did not identify a trend for lot 46236fp00 related to the customer issue, and a ticket search by lot 47343be00 indicates that the reagent lot was not associated with any other complaints of falsely elevated results.Furthermore, the overall performance of the alinity i ca 19-9xr reagent lot 46236fp00 was reviewed using field data from customers worldwide.Review shows that the median patient results for the reagent lot number 46236fp00 are within the established limits, which indicates no unusual reagent lot performance was identified.A labeling review determined product labeling provides adequate information regarding the customer issue.Based on the investigation, no systemic issue or deficiency with the alinity i ca 19-9xr reagent lot 46236fp00 was identified.

• 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: 16538843
• Report Number: 3002809144-2023-00123
• Device Sequence Number: 6007614
• Product Code: NIG
• UDI-Device Identifier: 00380740155919
• UDI-Public: 00380740155919
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K052000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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: 09/29/2023
• Device Model Number: 08P3221
• Device Catalogue Number: 08P32-21
• Device Lot Number: 46236FP00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• 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, AI20900; ALNTY I PROCESSING MODU, 03R65-01, AI20900
• Patient Sex: Unknown