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 02K91-24

Device Problem Low Test Results (2458)

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

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: multiple sids for one patient = (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely depressed architect ca19-9xr results for one patient.The following data was provided: on (b)(6) 2021, sid (b)(6), initial ca 19-9xr result was 156.89 u/ml, repeated >1200 u/ml, automatically diluted to 1:10 with a result of 10366 u/ml.On (b)(6) 2021, (same sample with new sid) sid (b)(6), initial result >1200 u/ml.No impact to patient management was reported.

Manufacturer Narrative

A ticket search by lot indicates that the reagent lot performs as expected for this product.Return testing was not completed as returns were not available.Trending review did not identify any trends for the complaint issue.Device history record review did not identify any issues associated with lot 23013m800 and the complaint issue.Historical performance of reagent lot 23013m800 was evaluated using worldwide data for the architect ca 19-9xr assay.The patient¿s data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 23013m800 is within the established control limits.Therefore, no unusual reagent lot performance was identified for 23013m800.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect ca 19-9xr reagent lot 23013m800 was identified.

• Brand Name: ARCHITECT CA19-9XR REAGENT KIT
• Type of Device: 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12605536
• MDR Text Key: 278009520
• Report Number: 3002809144-2021-00595
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K052000
• 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: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2021
• Device Catalogue Number: 02K91-24
• Device Lot Number: 23013M800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2SR REFURB-SEKAT, 03M74-97, (B)(4); ARC I2SR REFURB-SEKAT, 03M74-97, (B)(4)