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	12/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier does not contain enough spaces, the entire id is (b)(6).An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The account generated false elevated architect ca125 of 83.80 u/ml on (b)(6) 2019 with a female, (b)(6) patient with endometrial cancer.Historically, the patient had ca125 of 16.5 u/ml and had a total hysterectomy.No impact to patient management was reported.No ethnicity or race provided.
Additional Manufacturer Narrative
No customer returns were available for evaluation.Review of the ticket trending and lot search did not identify an increase in complaint activity related to the complaint issue.The historical performance of reagent lot and 03026m800 was evaluated using world wide data.The patient data was analyzed showing patient median results within established control limit for the complaint lot.No unusual reagent lot performance was identified for lot 03026m800.A device history record review was performed on lot 03026m800, which did not show any related potential non-conformances, deviations, or non-conformances.Labeling was reviewed and found to adequately address the issue under review.No product deficiency was identified.
Event or Problem Description
Additional information was provided: the account uses a normal ca125 reference range of <35.0 u/ml.
Additional Manufacturer Narrative
Section d3 and g1.2 manufacturer name is updated from abbott to abbott gmbh.An evaluation is in process.A followup report will be submitted when the evaluation is complete.Evaluation is in process.

• 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: 9542045
• Report Number: 3002809144-2020-00004
• Device Sequence Number: 16713323
• 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,Followup
• Report Date (Section B): 02/05/2020

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: 04/17/2020
• Device Model Number: 02K4529
• Device Catalogue Number: 02K45-29
• Device Lot Number: 03026M800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 01/07/2020; 01/10/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/07/2020; 02/06/2020
• 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 LIST 03M74-01; ARCHITECT I2000SR LIST 03M74-01; ARCHITECT I2000SR LIST 03M74-01; SERIAL (B)(4); SERIAL (B)(4); SERIAL (B)(4)
• Patient Age: 60 YR