MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT AFP; ALPHA-FETOPROTEIN

Catalog Number 03P36-25

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The account generated a falsely elevated architect afp of 27 iu/ml on a patient who usually tests around 3 iu/ml.The specimen was repeated with results of 2.7, 7 and 5.43 iu/ml.No impact to patient management reported.

Manufacturer Narrative

Review of customer quality control data run on date of event indicated controls were within range and no issues were identified through review of customer instrument logs.No customer returns were available for evaluation.The ticket searches determined normal complaint activity for the likely cause lot and the complaint trending report review determined that there is no non statistical or adverse trend for the issue for the product.An instrument data analytics (ida) report for list 3p36 was reviewed covering the timeframe 20 december 2015 to 18 jun 2016 which indicates that the lot is performing acceptably in the field.A review of the manufacturing documentation for the likely cause lot did not identify any issues associated with the customer observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on all available information and abbott diagnostics complaint investigation, the assay performed as intended and no product deficiency was identified.

Manufacturer Narrative

The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended at the customer site.However, no systemic issue and/or product deficiency was identified.

• Brand Name: ARCHITECT AFP
• Type of Device: ALPHA-FETOPROTEIN
• 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 ; 224667-512
• MDR Report Key: 5735528
• MDR Text Key: 47741620
• Report Number: 3008344661-2016-00043
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P120008
• 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,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2016
• Device Catalogue Number: 03P36-25
• Device Lot Number: 60193FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2016
• 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
• Patient Age: 4 YR