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

Catalog Number 02K91-78

Device Problem Low Test Results (2458)

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.Patient information: no further patient information was provided by the customer.This report is being filed on an international product, list number 2k91-78 that has a similar product distributed in the us, list number 2k91-33.

Event Description

The customer observed a falsely decreased architect ca 19-9xr results for 1 patient.The following data was provided for a patient diagnosed with chronic lymphocyte proliferation, with an unknown pancreatic cancer history: initial result = >1200 ng/ml, repeat automatic dilution 1:10 = 2167.43 ng/ml, repeat manual dilution 1:20 = 4657.6 ng/ml.No impact to patient management was reported.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed from architect ca19-9xr, list number 02k91-78, manufacturing site abbott wiesbaden, deu in this report to architect i2000sr processing module, list number 03m74-02, manufacturing site abbott irving, tx.Mdr number 1628664-2019-00693 has been submitted and all further information will be documented under that mdr number.

• 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: 9160290
• MDR Text Key: 189607400
• Report Number: 3002809144-2019-00586
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• 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: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02K91-78
• Device Lot Number: 01046M800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LIST 03M74-02; ARCHITECT I2000SR ANALYZER, LIST 03M74-02; SERIAL (B)(4).; SERIAL (B)(4).