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

Catalog Number	03P36-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated that a falsely elevated architect afp result of 43.89 ng/ml was generated for a patient sample that retested at 1.88 ng/ml.The customer's normal rsnge is 0.89 - 8.78 ng/ml.The elevated result does not fit the clinical picture.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for the likely cause lot.Labeling was reviewed and found to be adequate.Historical performance of the reagent lot was evaluated using world wide data from abbott link.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for this lot is within the established control limits which indicates that the lot is performing acceptably and comparable to other lots in the field.Based on the available information, no product deficiency was identified.

• Brand Name: ARCHITECT AFP
• Common Device Name: ALPHA-FETOPROTEIN
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 8680621
• Report Number: 3008344661-2019-00073
• Device Sequence Number: 11216552
• Product Code: LOK
• UDI-Device Identifier: 00380740112400
• UDI-Public: 00380740112400
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P120008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/19/2019
• Device Catalogue Number: 03P36-25
• Device Lot Number: 96123FN00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-02, SN (B)(4); LN 03M74-02,SN (B)(4)