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
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no additional patient information provided.
Event or Problem Description
The customer reported a false elevated ca125 initial result of 53.4 u/ml, when processing on the architect i2000sr.Another tube from the same sample generated a result of 14.3 u/ml.The sample was retested again and yielded results of 55.2 u/ml and 51.6 u/ml.A second sample was drawn and yielded results of 42.1 u/ml and 25.9 u/ml.Results from another architect gave a result of 28 u/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The evaluation of the customer issue included a review of complaint activity, tracking and trending review, a review of field data, and a review of labeling.Review of complaint activitiy determined there was normal complaint activity for the likely cause lot 92014m800.Tracking and trending report review for the architect ca 125 assay determined that there were no related adverse or non-statistical trends.Using worldwide field data, the performance of reagent lot 92014m800 was evaluated and median result was within the established control limits, therefore no unusual reagent lot performance was identified.Review of the device history was performed and no issues were identified.Labeling was reviewed and found to be adequate.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: 8296473
• Report Number: 3002809144-2019-00035
• Device Sequence Number: 2462761
• 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): 03/12/2019

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: 05/24/2019
• Device Catalogue Number: 02K45-29
• Device Lot Number: 92014M800
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 03/12/2019
• 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, LIST 03M74-02; ARCHITECT I2000SR, LIST 03M74-02; SERIAL (B)(4); SERIAL (B)(4)