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

Catalog Number 02K45-39

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 321331851
• Report Number: 3002809144-2023-00353
• Device Sequence Number: 1
• Product Code: LTK
• UDI-Device Identifier: 00380740145385
• UDI-Public: 00380740145385
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042731
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, ISR61935