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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete patient identification: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a false elevated afp initial result when processing on the architect i2000sr.The initial result was 581.87 and retest was 3.28 ng/ml.A new blood draw generated a result of 3.2 ng/ml.A previous afp result from 3 months prior was 3 ng/ml.Additional diagnostic testing was provided for this patient: (b)(6).Alt was 70 and ast was 40.No impact to patient management was reported.
Event or Problem Description
Addtional information from the customer stated that on admission the patient underwent an mri examination and the patient was discharged without any particular medication or treatment.
Additional Manufacturer Narrative
Event was updated to include additional information received from the customer regarding the event.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
An investigation was performed for the customer issue and included a review of the complaint text, testing of a retained kit of lot 91429fn00, a search for similar complaints, a review of trending data, a review of the historical performance for reagent lot 91429fn00, a review of product quality history, and a review of product labeling.Testing was performed using an in-house retained kit of lot 91429fn00 and all specifications were met indicating the lot is preforming acceptably.The ticket searches determined normal complaint activity for the likely cause lot.Complaint trending report review determined that there is no non-statistical or adverse trend for the product for the complaint issue.World wide data was used to review the historical performance of lot 91429fn00 and determined the patient median result for the lot is comparable with all other lots in the field and confirms no systemic issue for the lot.A review of the product quality history for the lot did not identify issues associated with the customer observation.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not 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: 8599438
• Report Number: 3008344661-2019-00067
• Device Sequence Number: 2074228
• Product Code: LOK
• UDI-Device Identifier: 00380740081317
• UDI-Public: 00380740081317
• 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,Followup
• Report Date (Section B): 07/29/2019

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: 08/29/2019
• Device Catalogue Number: 03P36-25
• Device Lot Number: 91429FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/05/2019
• Supplement Date Received by Manufacturer: 05/13/2019; 07/23/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/11/2019; 07/29/2019
• 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, LIST 03M74-02; SERIAL (B)(4)
• Patient Age: 41 YR