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	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 - patient identifier complete entry = sample id (b)(6) and sample id (b)(6) all available patient information was included.Additional patient details are not available.Section e1 - phone number complete entry = (b)(6).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 58183ud00 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 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 58183ud00, was identified.
Event or Problem Description
The customer observed false positive architect total b-hcg results for one patient.The following data was provided (/=25.00 miu/ml is positive): sample id (b)(6) initial result, on (b)(6) 2024, was 56.53 iu/ml, which was released from the laboratory.The result was questioned, so the sample was repeated on (b)(6) 2024, and the result was 60.13 iu/ml.The patient was recollected, under sample id (b)(6) and the result was 61.36 iu/ml.The samples were then sent to a reference laboratory where sample id (b)(6) result was <0.60 iu/ml, which is negative and sample id (b)(6) result was <0.60 iu/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: 19203815
• Report Number: 3005094123-2024-00215
• Device Sequence Number: 12767912
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: (01)00380740014964(17)241102(10)58183UD00
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 04/29/2024

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: 11/02/2024
• Device Catalogue Number: 07K78-25
• Device Lot Number: 58183UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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 I2SR REFURB-BRAZIL, 03M74-56, (B)(6)
• Patient Sex: Unknown