MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT AFP

Catalog Number 03P36-26

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2013

Event Type  malfunction  

Event Description

The customer stated that an architect afp result of 14 ng/ml was generated for a (b)(6) male patient with liver cancer.The patient's previous afp values were around 230 - 290 ng/ml.No patient treatment was performed between the previous elevated values and the current value of 14 ng/ml.The physician inquired as to why the afp value decreased to almost a normal value when no treatment was given to this liver cancer patient.No adverse impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(4).

• 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: 3553639
• MDR Text Key: 21876228
• Report Number: 3008344661-2014-00001
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03P36-26
• Device Lot Number: 32146LF00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2013
• Initial Date FDA Received: 01/06/2014
• 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 ANALYZER; LIST 03M74-01, SERIAL (B)(4)
• Patient Age: 75 YR