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
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed discrepant alpha 1 fetoprotein (afp) results on the architect analyzer.The following data provided: initial 14, repeats 10, 20 for a patient between the ages of 1 and 3 years old.There was no impact to patient management reported.
Additional Manufacturer Narrative
On march 19, 2019 additional patient details were provided.The child was diagnosed clinically with isolated mammoplasia.This was noted on clinical examination when the child presented with urinary tract infection at the age of 4 months.Sex hormones, hcg, tfts and general biochemistry were all normal (the child was 2 years old when seen last in opd).The expected result was expected to be normal in view of the above.An evaluation is still in process, a follow up report will be provided when the evaluation is completed.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, and a review of labeling.No adverse trend was identified for the customer's issue.No return patient sample was available.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within established control limits.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation 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: 8348266
• Report Number: 3008344661-2019-00016
• Device Sequence Number: 2017757
• Product Code: LOK
• UDI-Device Identifier: 00380740081317
• UDI-Public: 00380740081317
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 05/03/2019

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: 01/25/2019
• Supplement Date Received by Manufacturer: 03/19/2019; 05/01/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 04/09/2019; 05/03/2019
• 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; ARCHITECT I2000SR ANALYZER; LN 03M74-97 SN ISR01419; LN 03M74-97 SN ISR01419; LN 03M74-97 SN ISR01419
• Patient Age: 2 YR