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

Catalog Number	02K45-28
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2019
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.There is no further patient information provided due to privacy issues.
Event or Problem Description
The customer reported falsely elevated architect ca 125 results on one patient.The results provided were: (b)(6) 2019 on serial number (b)(4) = 53.4u/ml / on sn (b)(4) = 14.3u/ml; repeated on (b)(6) 2019, sn (b)(4) = 55.2u/ml / on (b)(6) 2019, sn (b)(4) = 51.6u/ml; second sample drawn tested on (b)(4) = 42.1u/ml / (b)(4) = 25.9u/ml; on another architect analyzer at a different site = 28u/ml.There was no reported impact to patient management.
Additional Manufacturer Narrative
Upon further review the manufacturer suspect medical device 3.Manufacturer name, city, and state and section.Manufacturing site was incorrect: from abbott, (b)(4).Mdr number 1415939-2019-00008 has been submitted and all further information will be documented under that mdr number.

• Brand Name: ARCHITECT CA 125 II
• Common Device Name: OC 125 DEFINED ANTIGEN
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 8293658
• Report Number: 3002809144-2019-00034
• Device Sequence Number: 1304181
• Product Code: LTK
• UDI-Device Identifier: 00380740145378
• UDI-Public: 00380740145378
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 02/13/2019

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: 07/26/2019
• Device Catalogue Number: 02K45-28
• Device Lot Number: 91010M800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 02/13/2019
• 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, LIST # 03M74-02.; ARCHITECT I2000SR ANALYZER, LIST # 03M74-02.; SERIAL # (B)(4).; SERIAL # (B)(4).