MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT CA125 II REAGENT KIT; TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)

Catalog Number	02K45-39
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased architect ca 125 ii results generated on the architect i2000sr processing module for one patient sample.The following information was provided: ca125 = 28.9 u/ml, additional laboratory data provided: cea: 21.6 ng/ml, wbc: 25,000, crp:± the patient¿s previous values with the same platform: (b)(6) ca125 = 271 u/ml, cea: 12.2 ng/ml, crp: ± (b)(6) ca125 = 239 u/ml, cea: 11.4 ng/ml, crp: 1+ the customer reported the patient is elderly undergoing steroid treatment.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for false decreased architect ca 125 ii results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.The device history record review did not identify any non-conformances or deviations with lot number 48325fp00 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Customer field data was used to assess the performance of the architect ca 125 ii assay using worldwide data.Review shows that the median patient result for lot 48325fp00 is within established limits and comparable with other lots in the field, confirming no systemic issue for lot 48325fp00.Based on the investigation, no systemic issue or deficiency with the architect ca 125 ii assay for lot 48325fp00 was identified.All available patient information was included.Additional patient details are not available.

• Brand Name: ARCHITECT CA125 II REAGENT KIT
• Common Device Name: TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17548138
• Report Number: 3002809144-2023-00353
• Device Sequence Number: 17858396
• Product Code: LTK
• UDI-Device Identifier: 00380740145385
• UDI-Public: 00380740145385
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2023

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: 11/23/2023
• Device Catalogue Number: 02K45-39
• Device Lot Number: 48325FP00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2023
• Initial Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: ARC I2K PROC MOD, 03M74-01, ISR61935
• Patient Sex: Unknown