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

Catalog Number 02K91-32

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 07/26/2018

Event Type  Injury  

Manufacturer Narrative

Unnecessary invasive diagnostic tests were performed, with no further negative impact.This report is being filed on an international product, architect ca19-9 list 02k91-32 that has a similar product distributed in the us, list number 02k91-29 and 02k91-33.

Event Description

The customer observed a falsely elevated ca19-9 result for one patient on the architect i2000sr analyzer.The following data was provided for a patient of unknown gender and unknown age sid (b)(6): at a physical check-up 3 months ago, a result of 100 u/ml was obtained, repeated at a later date (date unknown) as 80 u/ml.Repeated (b)(6) 2018 as 201 u/ml.An echo examination, ct examination without contrast, upper and lower endoscopy were performed.No cancer was found.No adverse impact to patient management from these additional invasive diagnostic tests were reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, and a review of labeling.No adverse trend was identified for the customer's issue.No return patient sample was available.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within established control limits.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• 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: 7738473
• MDR Text Key: 115658661
• Report Number: 3002809144-2018-00102
• 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: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2018
• Device Catalogue Number: 02K91-32
• Device Lot Number: 82033M800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-01 SN (B)(4); LN 03M74-01 SN (B)(4); ARCHITECT I2000SR ANALYZER; LN 03M74-01, SN: (B)(4)
• Patient Outcome(s): Other