MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT AFP

Catalog Number 03P36-26

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2014

Event Type  malfunction  

Event Description

The account generated a falsely elevated architect afp of 117.68 ng/ml on a patient sample that repeated <20 ng/ml (autodilution), 0.73 ng/ml and 0.75 ng/ml.Testing was performed on the patient for oncology purposes.No additional specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

(b)(4).A followup report will be submitted when the evaluation is complete.An evaluation is in progresss.

• Brand Name: ARCHITECT AFP
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• Manufacturer (Section G): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• 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: 3625431
• MDR Text Key: 19020688
• Report Number: 3008344661-2014-00010
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P120008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03P36-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2014
• 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 I2000SR, LIST 03M74-01; SERIAL (B)(6).; SERIAL (B)(4); ARCHITECT I2000SR, LIST 03M74-01