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

Catalog Number 02K45-78

Device Problem Low Test Results (2458)

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

Event Date 12/26/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Initial reporter's name and address - facility name: complete facility name is (b)(6).Initial reporter's name and address - address 1: complete address 1 is (b)(6).

Event Description

The customer observed falsely decreased architect ca 125 ii result for one patient that is not consistent with the patient¿s historical result.It is unknown if the patient has been diagnosed with ovarian cancer.The following data was provided: reference range is < /= 35 u/ml architect ca 125 result = 50 u/ml previous result from another hospital (abbott platform) = 100 u/ml no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely decreased architect ca 125 ii result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.In-house testing of retained reagent kit was also completed.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.Ticket search by lot indicates that the reagent lot performs as expected for this product.Ticket trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 42957fp00 and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.An in-house testing of a retained reagent kit of the complaint lot was performed using panels which mimic patient samples.All specifications were met indicating that the lot is performing acceptably.Based on this investigation, no systemic issue or deficiency was identified for the architect ca 125 ii reagent lot 42957fp00.

• 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: 16172203
• MDR Text Key: 308666186
• Report Number: 3002809144-2023-00033
• Device Sequence Number: 1
• Product Code: LTK
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2023
• Device Catalogue Number: 02K45-78
• Device Lot Number: 42957FP00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6)