MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY CA 125 II REAGENT; CANCER ANTIGEN 125 KIT

Catalog Number	08P49-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2019
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 reported a falsely elevated alinity i ca125 result on one patient.Results provided: (b)(6) 2019 = 136 u/ml; new sample tested at another laboratory (method unknown) = 16; new sample from other laboratory processed on this alinity = 16 u/ml.It is unknown if the patient is diagnosed with ovarian cancer.No impact to patient management was reported.
Additional Manufacturer Narrative
A review of complaints for the alinity i ca 125 ii (list 8p49), lot# 93256fp00 assay determined that there are no trends for the product related to patient results.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the customers observation.Accuracy testing was performed on lot# 93256fp00 with an internal ca 125 panel and all criteria was met indicating acceptable product performance.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity i ca125 ii (list 8p49), lot# 93256fp00 assay.

• Brand Name: ALINITY CA 125 II REAGENT
• Common Device Name: CANCER ANTIGEN 125 KIT
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8983835
• Report Number: 3002809144-2019-00550
• Device Sequence Number: 16212237
• Product Code: LTK
• UDI-Device Identifier: 00380740131043
• UDI-Public: 00380740131043
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2019
• Device Catalogue Number: 08P49-20
• Device Lot Number: 93256FP00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/01/2019
• 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 I PROCESSING MODULE LIST 03R65-01; ALINITY I PROCESSING MODULE LIST 03R65-01; SERIAL (B)(4); SERIAL (B)(4)