MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT AFP

Catalog Number 03P36-30

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reports a falsely elevated architect afp assay result for one patient serum sample generated on an architect i2000sr analyzer.The patient was scheduled for the repair of an adult inguinal hernia.As part of the pre-operation screening, an architect afp was ordered and generated an initial result of 1376 ug/ml and questioned by physicians.An ultrasound and ct scan were performed and showed no abnormalities.Other tumor markers were negative.The sample retested at 2 ug/ml.Additional samples tested also generated a result of 2 ug/ml.There has been no impact to patient management reported other than the delay of the surgery.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(4).(b)(6).

Manufacturer Narrative

An abbott field service representative visited the customer site and verified no issues with the architect (b)(4) analyzer.No customer returns were available for this evaluation.A review of architect afp complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.The product evaluation did not include any testing of the suspect reagent lot 32152lf00 as re-testing of the patient sample by the customer consistently generated the expected lower result, which indicates that the customer issue is not reagent lot specific.A review of the manufacturing documentation did not identify any issues associated with the customer issue.The architect afp assay package insert and the architect (b)(4) operations manual both contain information to address the current customer issue.Based on a review of the information from the customer site and the results of the current evaluation, it was determined that the architect afp assay, lot 32152lf00, is performing as expected.A product malfunction was not identified.

• 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: 3698427
• MDR Text Key: 4250322
• Report Number: 3008344661-2014-00016
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Type of Report: Initial,Followup
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/14/2014
• Device Catalogue Number: 03P36-30
• Device Lot Number: 32152LF00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR LN:03M74-02 SN:(B)(4); ARCHITECT I2000SR LN:03M74-02 SN:(B)(4)