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

Catalog Number 02K91-39

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no further patient information provided by the customer.This report is being filed on an international product, list number 2k91-39 that has a similar product distributed in the us, list number 2k91-33.

Event Description

The customer reported falsely elevated architect ca19-9 results on one patient sample.The results provided were: initial ca19-9 = 202.2 / retest = < 2.The patient's disease state is unknown.There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets for the architect ca19-9xr assay was performed.The review did not identify any trends that indicate a product issue related to patient results.A ticket review was completed for lot number 84019m800 and did not find an increase in complaints for the issue.Return testing was not completed as returns were not available.Historical performance of reagent lot 84019m800 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 84019m800 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 number 84019m800.

• 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
• MDR Report Key: 8024854
• MDR Text Key: 125674103
• Report Number: 3002809144-2018-00496
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• PMA/PMN Number: K052000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2018

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: 12/21/2018
• Device Catalogue Number: 02K91-39
• Device Lot Number: 84019M800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 11/08/2018
• Supplement Dates FDA Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,; SERIAL # (B)(4); SERIAL # (B)(4); ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,; SERIAL # (B)(4).