MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I CA 19-9XR; CA19-9

Model Number	08P3221
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely elevated ca19-9 result on the alinity analyzer.The following data was provided: case 2 (b)(6): male dob (b)(6) 1969 diagnosed with an unknown type of cancer: initial 812.92, repeat 1717.82 u/ml (111% shift).There was no negative impact to patient management reported.
Additional Manufacturer Narrative
A review of ticket trending data for the alinity i ca19-9xr assay and complaint lot lot number 13604fp00 was performed.The review did not identify any adverse trends or increase of complaint activity that indicate a product issue related to patient results.Accuracy testing was performed to evaluate the performance of reagent lot 13604fp00.Acceptance criteria were met, which indicates acceptable product performance.A device history record review was performed on reagent lot 13604fp00, which did not show any potential non-conformances, deviations, or non-conformances.Labeling was reviewed and found to adequately address the issue under review.No customer returns were available for evaluation.No product deficiency was identified.

• Brand Name: ALINITY I CA 19-9XR
• Common Device Name: CA19-9
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9865054
• Report Number: 3002809144-2020-00205
• Device Sequence Number: 525075
• Product Code: NIG
• UDI-Device Identifier: 00380740155919
• UDI-Public: 00380740155919
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (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): 04/22/2020

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: 12/08/2020
• Device Model Number: 08P3221
• Device Catalogue Number: 08P32-21
• Device Lot Number: 13604FP00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/23/2020
• 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: ALINITY ANALYZERS; ALINITY ANALYZERS; LN 03R65-01 SN (B)(6) ; LN 03R65-01 SN (B)(6)