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	02/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false positive architect total b-hcg results for a 34-year-old female patient.The following data was provided (<5.00 miu/ml is negative, >/=25.00 miu/ml is positive): sample id (b)(6) initial result, on (b)(6) 2024, was 3.39, repeat results were 399.01 and 4.38 miu/ml.The sample was also tested for troubleshooting with an alinity assay, and the result was 154.01, repeat results were 424.30 and 410.45 miu/ml.A new sample was collected from the patient and the result was 3.75 miu/ml.The patient¿s previous result on (b)(6) 2024 was 187.0, on (b)(6) 2024 was 29.0, and on (b)(6) 2024 was <1.20 miu/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The complaint investigation for a false positive architect total b-hcg result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Trending review determined no related trend for the product.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Device history record review on lot number 55314ud00 did not identify any non-conformances or deviations with the likely cause lot.The overall performance of architect total b-hcg reagents in the field was reviewed using data gathered from customers worldwide, with median values (for the negative population) for the complaint lot within the established limits, suggesting that the performance is acceptable.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of architect total b-hcg, lot number 55314ud00, was identified.
Event or Problem Description
The customer observed false positive architect total ¿-hcg results for a 34-year-old female patient.The following data was provided (<5.00 miu/ml is negative, >/=25.00 miu/ml is positive): sample id (b)(6) initial result, on (b)(6) 2024, was 3.39, repeat results were 399.01 and 4.38 miu/ml.The sample was also tested for troubleshooting with an alinity assay, and the result was 154.01, repeat results were 424.30 and 410.45 miu/ml.A new sample was collected from the patient and the result was 3.75 miu/ml.The patient¿s previous result on (b)(6) 2024 was 187.0, on (b)(6) 2024 was 29.0, and on (b)(6) 2024 was <1.20 miu/ml.There was no impact to patient management reported.

• 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: 18790623
• Report Number: 3005094123-2024-00081
• Device Sequence Number: 12702036
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: (01)00380740014964(17)240810(10)55314UD00
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 04/25/2024

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: 08/10/2024
• Device Catalogue Number: 07K78-25
• Device Lot Number: 55314UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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, ISR60942.; ARC I2000SR INST, 03M74-02, ISR60942.
• Patient Sex: Unknown