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

Catalog Number	02K45-29
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 reported falsely elevated architect ca 125 results on one patient diagnosed with ovarian cancer.The results provided were: pt#1: on (b)(6) 2017 = 85.6u/ml; on (b)(6) 2017 = 74.3u/ml; on (b)(6) 2019 = 665.7 u/ml, sample was re-spun and retested = 674.9 and 665.7u/ml; on (b)(6) 2019 = 81.9 u/ml.There was no reported impact to patient management.
Additional Manufacturer Narrative
The review of tickets determined no additional complaints for lot 93002m800 and no trends were found for falsely elevated patient results.Return testing was not completed as returns were not available.Historical performance in the field of lot 93002m800 using world wide data through abbottlink was evaluated.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result is within the established control limits.Therefore, no unusual reagent lot performance was identified.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of labeling concluded that the issue is sufficiently addressed in the labeling.Based on the investigation no product deficiency was identified for the architect ca 125 ii, lot 93002m800.

• Brand Name: ARCHITECT CA 125 II
• Common Device Name: OC 125 DEFINED ANTIGEN
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8860768
• Report Number: 3002809144-2019-00482
• Device Sequence Number: 525476
• 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): 09/12/2019

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: 08/01/2019
• Device Catalogue Number: 02K45-29
• Device Lot Number: 93002M800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 09/12/2019
• 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: ARCHITECT I2000SR ANALYZER, LN 03M74-01; ARCHITECT I2000SR ANALYZER, LN 03M74-01; SERIAL # (B)(4); SERIAL # (B)(4)