MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I CA 19-9XR; CA19-9

Catalog Number 08P32-20

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

Manufacturer Narrative

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 8p32-20 that has a similar product distributed in the us, list number 8p32-21.

Event Description

The customer observed falsely decreased alinity i ca 19-9xr results on one patient.The results were provided: initial ca19-9 result(heparin plasma) on ai01229=>1200 u/ml/ auto dilution 1:5 ca19-9 result=243 u/ml/ repeated on other alinity ai01221 ca19-9 result=1082 u/ml/ 1:10 dilution result=212 u/ml/ manual dilution 1:10 ca19-9 result=406.U/ml, on serum specimen ca19-9 result=>1200 u/ml/auto dilution 1:5 ca19-9 result=315.8 u/ml.The comparison data attached sid ranging 040041108027 to 040041544008 on sn (b)(4) results <2.06 u/ml to >1200.0 u/ml, sid ranging 040040803120 to 040040945023 results ranging <2.1 u/ ml to >1200.0 u/ml.There was no impact to patient management.

Manufacturer Narrative

A review of tickets was performed for alinity i ca19-9xr reagent lot number 11568fp00.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.The accuracy testing was performed using an internal panel which was tested with a retained kit of the likely cause reagent lot.Acceptance criteria were met, indicating acceptable product performance.Further investigation of the customer issue included a review of the complaint text, review of product historical data, device history record review and a review of labeling.No discrepant results were obtained.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 alinity i ca19-9xr reagent, lot 11568fp00.

• Brand Name: ALINITY I CA 19-9XR
• Type of Device: CA19-9
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10024312
• MDR Text Key: 190166273
• Report Number: 3002809144-2020-00368
• 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: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2020
• Device Catalogue Number: 08P32-20
• Device Lot Number: 11568FP00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE.; ALINITY I PROCESSING MODULE.; LIST # 03R65-01, SERIAL # (B)(6). ; LN 03R65-01 SERIAL (B)(6).