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	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 - patient identifier - (b)(6) (2 different patients) all available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported false positive architect total b-hcg results generated on the architect i2000sr analyzer for 2 patients.The following data was provided: patient 1, sid (b)(6): (b)(6) 2024 = 528.32 miu/ml (b)(6) 2024 = < 1.20 miu/ml (b)(6) 2024 = < 1.20 miu/ml (b)(6) 2024 = < 1.20 miu/ml these are samples from different collections.Patient 2, sid (b)(6): (b)(6) 2024 = 277.92 miu/ml (b)(6) 2024 = < 1.20 miu/ml the results above are from the same sample.The reference range for b-hcg is /= 25.00 miu/ml is positive.There was no impact to patient management reported.
Event or Problem Description
The customer reported false positive architect total b-hcg results generated on the architect i2000sr analyzer for 2 patients.The following data was provided: patient 1, sid (b)(6): (b)(6) 2024 = 528.32 miu/ml.(b)(6) 2024 = < 1.20 miu/ml.(b)(6) 2024 = < 1.20 miu/ml.(b)(6) 2024 = < 1.20 miu/ml.These are samples from different collections.Patient 2, sid (b)(6): (b)(6) 2024 = 277.92 miu/ml.(b)(6) 2024 = < 1.20 miu/ml.The results above are from the same sample.The reference range for b-hcg is /= 25.00 miu/ml is positive.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation 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 in-house testing with a retained kit of the complaint lot.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A search for similar complaints did identify a slight increase in complaint activity for lot 58456ud00, however, no related trends were identified regarding commonalities for complaint lot number and issue.Additionally, accuracy testing was completed with a retained kit of the complaint lot.All validity and acceptance criteria were met, indicating that the lot is performing as expected.A review of the device history record did not identify any potential non-conformances, non-conformances, or deviations associated with the lot number and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for architect total b-hcg reagent lot 58456ud00.

• 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: 19541226
• Report Number: 3005094123-2024-00322
• Device Sequence Number: 20759374
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: (01)00380740014964(17)241117(10)58456UD00
• 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): 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): 08/08/2024

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: 07K78-25
• Device Lot Number: 58456UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 08/08/2024
• 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 I2K PROC MOD, 03M74-01, (B)(6); ARC I2K PROC MOD, 03M74-01, (B)(6)
• Patient Sex: Unknown