MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Catalog Number	07K78-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier = sid= (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 observed false positive architect b-hcg results on one female patient.The results provided were: on (b)(6) 2024 ,sid (b)(6), initial=2094.07 miu/ml (> or =25.00 miu/ml=positive) /repeated=< 1.2 miu/ml (< or =5.00 miu/ml=negative) /repeated on (b)(6) 2024=< 1.2 miu/ml there was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation for false positive architect total b-hcg results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, field data review, and labeling review of architect total b-hcg reagent, lot 56209ud00.Return testing was not completed as returns were not available.The ticket search determined that there is as expected complaint activity for the likely cause lot.A review of tracking and trending data did not identify any related trends for the product for the issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Historical performance of the architect total b-hcg reagents in the field was reviewed using data gathered via abbottlink from customers worldwide.The median value of the negative population for the complaint lot is within the established limits and comparable with other lots in the field which confirms no systemic issue for the lot.A review of labeling was performed and found to and sufficiently address the customer's issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on this investigation, no systemic issue or deficiency was identified for the architect total b-hcg reagent lot 56209ud00.
Event or Problem Description
The customer observed false positive architect b-hcg results on one female patient.The results provided were: on (b)(6) 2024 sid (b)(6) initial=2094.07 miu/ml (> or =25.00 miu/ml=positive) /repeated=< 1.2 miu/ml (< or =5.00 miu/ml=negative) /repeated on (b)(6) 2024=< 1.2 miu/ml there was no reported impact to patient management.

• Brand Name: ARCHITECT TOTAL B-HCG REAGENT KIT
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18645767
• Report Number: 3005094123-2024-00047
• Device Sequence Number: 12559390
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: (01)00380740014964(17)240901(10)56209UD00
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K983424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 04/01/2024

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: 09/01/2024
• Device Catalogue Number: 07K78-25
• Device Lot Number: 56209UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2SR REFURB-SEKAT, 03M74-97, ISR63069; ARC I2SR REFURB-SEKAT, 03M74-97, ISR63069
• Patient Sex: Female