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

Catalog Number	07K78-74
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information from section a1.Sid: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information has been included.No additional patient details are available.
Event or Problem Description
The customer observed falsely elevated architect total b-hcg results for one patient.The initial result for sid: (b)(6) was 306.05 miu/ml, re-test <1.2 miu/ml (reference range <5 unit: miu/ml).No impact to patient management was reported.
Additional Manufacturer Narrative
Corrected information found in section d4.Lot number and catalogue number.Data and information provided by the customer were reviewed and support the complaint issue.The lot search review did not identify an increase in complaint activity for the issue.Return testing was not completed as returns were not available.Ticket trending review did not identify any trends.Device history record review was performed on lot 58456ud01, which did not show any potential non-conformances, deviations, or non-conformances related to the issue under review.Customer field data was used to assess the performance of the architect total b-hcg assay using worldwide data.Review shows that the median patient result for the lot is within established limits and comparable with other lots in the field, confirming no systemic issue for the lot.Labeling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency of the architect total b-hcg assay was identified.

• 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: 18934904
• Report Number: 3005094123-2024-00132
• Device Sequence Number: 6971207
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: 00380740014964
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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: 11/17/2024
• Device Catalogue Number: 07K78-74
• Device Lot Number: 58456UD01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR INST, 03M74-02, ISR63795.; ARC I2000SR INST, 03M74-02, ISR63795.
• Patient Sex: Unknown