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 Type  malfunction  

Event Description

The account generated a false elevated architect afp of 251.83 ng/ml on a patient id (b)(6) that repeated <2.00 ng/ml.No specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

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

Manufacturer Narrative

No customer return sample was available for evaluation.The ticket searches determined that there is no unusual activity for the likely cause lot.There is no adverse trend for the product and the complaint trending report review determined that there is no non statistical trend for the issue.Testing of panels which mimic patient samples using in-house retained kits were performed; all specifications were met indicating that the lot is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customer observation.A review of architect afp package insert and architect systems operations manual showed adequate labeling to assist the customer with inconsistent/discrepant results.No product deficiency was identified and no additional issues were identified during the evaluation of this complaint.

Event Description

Additional patient information was provided.The patient has liver cirrhosis, hemorrhagic anemia, femoral fractures, diabetes and colon polyps.There is no history in cancer for this patient.

• 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: 3644941
• MDR Text Key: 4352304
• Report Number: 3008344661-2014-00014
• 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
• Type of Report: Initial,Followup
• Report Date: 02/03/2014

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: Other
• Device Expiration Date: 03/15/2014
• Device Catalogue Number: 03P36-26
• Device Lot Number: 27500LF00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 02/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SERIAL (B)(4); SERIAL (B)(4); ARCHITECT I2000SR, LIST 03M74-01; ARCHITECT I2000SR, LIST 03M74-01
• Patient Age: 76 YR