MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT CA 19-9XR

Catalog Number 02K91-32

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

Complete information for patient information, patient identifier = (b)(6).This report is being filed on an international product, list number 2k91-32 that has a similar product distributed in the us, list number 2k91-33.There was no further patient information provided by the customer.A review of complaints found no other complaints for the architect ca19-9xr assay, lot 85040m800 and no trends for the product in the field.Return testing was not completed as returns were not available.Historical performance of reagent lot 85040m800 was evaluated using world wide data from abbott link.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 85040m800 is within the established control limits.Therefore, no unusual reagent lot performance was identified.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of labeling concluded that the issue is adequately addressed.Based on the investigation no product deficiency was identified for architect ca19-9xr, lot 85040m800.

Event Description

The customer reported falsely elevated architect ca19-9 results on one pancreatic cancer patient.The results provided were: on (b)(6) 2018, sid: (b)(6), ca19-9 = 87.16u/ml / 9.15 / 7.23u/ml.There was no reported impact to patient management.

• Brand Name: ARCHITECT CA 19-9XR
• Type of Device: CA 19-9
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 7990536
• MDR Text Key: 126235060
• Report Number: 3002809144-2018-00455
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Type of Report: Initial
• Report Date: 10/22/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2019
• Device Catalogue Number: 02K91-32
• Device Lot Number: 85040M800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1