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

Catalog Number 02K91-28

Device Problem Low Test Results (2458)

Patient Problem No Code Available (3191)

Event Date 10/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4): diagnostic imaging performed, it's unknown if iv contrast was used, or the impact to patient management.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.An evaluation is in process.

Event Description

The customer observed a falsely depressed ca19-9 result on the architect i2000sr analyzer.The patient ((b)(6)) has not been diagnosed with pancreatic cancer and is suspected to have ovarian cancer.The following data was provided: initial 15.46, repeat 15.20 u/ml.A value of 270 was obtained on another method at another facility.The patient underwent an image diagnosis and it is unknown if iv contrast was used.No further details regarding the patient or procedure could be obtained.

Manufacturer Narrative

On (b)(6) 2016 additional information was provided by the customer.The imaging was performed due to the other hospitals results.The ca19-9 results did not cause the imaging.Based upon this new information, this complaint is no longer a reportable event.

• Brand Name: ARCHITECT CA 19-9XR
• Type of Device: CA 19-9
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6061604
• MDR Text Key: 58539544
• Report Number: 1415939-2016-00102
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K052000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02K91-28
• Device Lot Number: 62015M800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; LN (B)(4) SN (B)(4)
• Patient Outcome(s): Other