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

Catalog Number 02K91-24

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Manufacturer Narrative

Complete information for section a patient information, patient identifier: (b)(6).There was no further patient information provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 2k91-24 that has a similar product distributed in the us, list number 2k91-33.

Event Description

The customer observed discrepant architect ca 19-9xr results on one patient.The results provided were: sid (b)(6) ca 19-9xr results=>1200 u/ml, auto 1:10 dilution=92 u/ml and 85 u/ml, manual 1:5 dilution =232.29 u/ml/1:10 dilution=113.64 u/ml, previous history in 2019= >1200 u/ml/repeated=113 u/ml.There was no reported impact to patient management.The patient diagnosis is unknown.

Manufacturer Narrative

A review of tickets was performed for reagent architect ca 19-9xr lot number 10030m800.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Historical performance of reagent lot 10030m800 was evaluated using world wide data from abbottlink.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 10030m800 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 the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect ca19-9xr reagent, lot 10030m800.

• Brand Name: ARCHITECT CA 19-9XR
• Type of Device: CA 19-9
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10376279
• MDR Text Key: 202008888
• Report Number: 3002809144-2020-00786
• 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: 09/10/2020

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: 11/14/2020
• Device Catalogue Number: 02K91-24
• Device Lot Number: 10030M800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 09/08/2020
• Supplement Dates FDA Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LIST # 03M74-02, SERIAL # (B)(6); LIST # 03M74-02, SERIAL # (B)(6)