MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT CA 125 II; OC 125 DEFINED ANTIGEN

Model Number	02K4529
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2020
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 architect ca 125 ii result on an (b)(6) female patient diagnosed with ovarian cancer and squamous cell carcinoma.Results provided: (b)(6) 2020 = 17.0 u/ml; (b)(6) 2020 = 30.3 u/ml; (b)(6) 2020 = 99.2 u/ml; (b)(6) 2020 = 9.0 u/ml (reference range: <35.0 u/ml).No impact to patient management was reported.
Additional Manufacturer Narrative
A review of complaints for the architect ca 125 ii, lot# 08015m800 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 customer's observation.Historical performance in the field of reagent lots using world wide data through abbottlink was evaluated.The patient median result for lot 08015m800 was analyzed and found to be within established baselines and confirms no systemic issues for this lot.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect ca125 ii, lot# 08015m800 assay.

• Brand Name: ARCHITECT CA 125 II
• Common Device Name: OC 125 DEFINED ANTIGEN
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10269889
• Report Number: 3002809144-2020-00656
• Device Sequence Number: 10965534
• Product Code: LTK
• UDI-Device Identifier: 00380740145378
• UDI-Public: 00380740145378
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/14/2020

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: 09/17/2020
• Device Model Number: 02K4529
• Device Catalogue Number: 02K45-29
• Device Lot Number: 08015M800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 07/14/2020
• 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: ARCHITECT I2000SR ANALYZER LIST 03M74-01; ARCHITECT I2000SR ANALYZER LIST 03M74-01; SERIAL (B)(6); SERIAL (B)(6)
• Patient Age: 80 YR