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

Catalog Number	02K45-39
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2019
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.Patient information: there was no additional patient information provided by the customer.
Event or Problem Description
The customer reported a falsely elevated architect ca 125 ii result for a patient undergoing treatment for ovarian cancer.The following results were provided for the patient: on (b)(6) 2019: 68 u/ml.On (b)(6) 2019: 2738 u/ml.On (b)(6) 2019: 1560 u/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data and a review of labeling.Review of complaint activity did not identify any adverse or non-statistical trends for the architect ca 125 ii assay.An increase in complaint activity was not identified for falsely elevated results with reagent lot 92024m800.Using worldwide field data the historical performance of the complaint lot was evaluated.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 92024m800 is within the established control limits.Therefore, no unusual reagent lot performance was identified for the lot.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect ca 125 ii assay was identified.

• 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: 8706156
• Report Number: 3002809144-2019-00325
• Device Sequence Number: 13914526
• Product Code: LTK
• UDI-Device Identifier: 00380740145385
• UDI-Public: 00380740145385
• 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): 07/17/2019

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: 02K45-39
• Device Lot Number: 92024M800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 07/17/2019
• 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, LIST 03M74-01; ARCHITECT I2000SR, LIST 03M74-01; SERIAL (B)(4); SERIAL (B)(4)