MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number	7K78-30
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer observed a false positive architect total b-hcg result for one patient.The following data was provided (<5.00 miu/ml is negative, >/=25.00 miu/ml is positive): (b)(6).There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for a falsely elevated 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, field data review, and testing of the complaint lot.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 21034ui00 did not identify any non-conformances or deviations with the likely cause lot.Accuracy testing was performed using panels, which mimics patient samples, and an in-house retained kit of lot 21034ui00, stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.The overall performance of architect total b-hcg reagents in the field was reviewed using data gathered via abbottlink from customers worldwide and suggested 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 21034ui00, was identified.Section d10 concomitant product added.

• Brand Name: ARCHITECT TOTAL B-HCG REAGENT KIT
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 11924851
• Report Number: 3005094123-2021-00105
• Device Sequence Number: 14410801
• Product Code: DHA
• UDI-Device Identifier: 00380740014971
• UDI-Public: 00380740014971
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 07/09/2021

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: 10/01/2021
• Device Model Number: 7K78-30
• Device Catalogue Number: 07K78-30
• Device Lot Number: 21034UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/09/2021
• 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, (B)(6)