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

Catalog Number 02K91-25

Device Problem High Test Results (2457)

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199); Test Result (2695)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

The customer questioned the architect ca19-9 generated from one patient.The patient is an (b)(6) female with acute pneumonia and eating disorder but no history of cancer.A result of 4978 u/ml was generated back in (b)(6) along with a high crp which indicated an inflammation.A new sample from the same patient generated a result of 62.18 u/ml on (b)(6) and repeated at 74.57 u/ml.Another sample was tested on (b)(6) with a result of 7.11 u/ml, repeated at 13.17 u/ml.No treatment was administered to the patient between (b)(6).However, the patient died on (b)(6) due to myocardial infarction and acute circulatory failure.The customer did not allege a malfunction of the architect ca19-9 assay could have caused or contributed to the death of the patient.The physician suspected the patient to have a diagnosis of either lung cancer, pancreatic cancer or colon cancer.A medical assessment was obtained which indicated that the architect ca19-9 reagent did not cause or contribute to the death of the patient (given the information presented, it does not appear that the ca 19-9 results caused or contributed to the patient's myocardial infarction and acute circulatory failure).

Manufacturer Narrative

This report is being submitted against an ex-us product (02k91-25) that has a similar product (02k91-27) distributed in the us.(b)(4).Product evaluation is in process and the results will be submitted in a follow-up report.

Manufacturer Narrative

Additional information received on july 14th, indicated that the product lot 30042m500 is not a likely cause of this issue.

• 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 350
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 350
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 847937-512
• MDR Report Key: 3677930
• MDR Text Key: 20716295
• Report Number: 1415939-2014-00069
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02K91-25
• Device Lot Number: 30042M500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2K ANALYZER 03M74-01SN (B)(4)
• Patient Age: 85 YR