MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT CA19-9XR REAGENT KIT; SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER

Catalog Number	02K91-33
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
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.All available patient information has been included.No additional patient details are available.
Event or Problem Description
The customer observed falsely depressed architect ca 19-9 results for one patient diagnosed with pancreatic cancer.The following data was provided: on (b)(6) 2024, sid (b)(6) was sent from an outpatient facility.The architect ca 19-9 result was <2 u/ml, repeated <2 u/ml.On (b)(6) 2024, the same patient with different sid (sid (b)(6)) was sent from an outpatient facility.The architect ca 19-9 result was 40,243 u/ml.The customer retested the sample from (b)(6) 2024 (sid (b)(6)) and the retest was 30,360 u/ml.No impact to patient management was reported.
Event or Problem Description
The customer observed falsely depressed architect ca 19-9 results for one patient diagnosed with pancreatic cancer.The following data was provided: on (b)(6) 2024, sid (b)(6) was sent from an outpatient facility.The architect ca 19-9 result was <2 u/ml, repeated <2 u/ml.On (b)(6) 2024, the same patient with different sid (sid (b)(6) was sent from an outpatient facility.The architect ca 19-9 result was 40,243 u/ml.The customer retested the sample from (b)(6) 2024, (sid (b)(6) and the retest was 30,360 u/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation 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.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot.The overall performance of the architect ca 19-9xr reagents in the field was reviewed using data gathered from customers worldwide.The patient median values obtained with the complaint lot 59924fp00 is within established limits and thus comparable to the historical lot performance, which confirms no systemic issue for the lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect ca 19-9xr reagent lot 59924fp00 was identified.

• Brand Name: ARCHITECT CA19-9XR REAGENT KIT
• Common Device Name: SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER
• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19527385
• Report Number: 3002809144-2024-00170
• Device Sequence Number: 18029902
• Product Code: NIG
• UDI-Device Identifier: 00380740137304
• UDI-Public: (01)00380740137304(17)241105(10)59924FP00
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K052000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: 11/05/2024
• Device Catalogue Number: 02K91-33
• Device Lot Number: 59924FP00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Sex: Unknown