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 Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2021
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.
Event or Problem Description
The customer reported a false positive architect total b-hcg result for a patient.The following data was provided (reference range = /= 25.00 iu/l = positive).On (b)(6) 2021 sid (b)(6) = initial result = 29 iu/l (positive), repeat result = < 1 iu/l (negative) there was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for false elevated result for one patient when tested with the architect total b-hcg assay 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 in house testing of retained kits with the complaint lot number.Return testing was not completed as returns were not available.Trending review determined no trends were identified for the product.Device history record review did not identify any non-conformances or deviations with lot 15730ui00.Accuracy testing was completed using an inhouse retained kit of lot 15730ui00.All validity and acceptance criteria have been met demonstrating that the lot is performing acceptably.The overall performance of architect total b-hcg reagents in the field was reviewed using data gathered from customers worldwide and suggested that the performance of the lot is acceptable.Labeling review concluded that the issue was adequately addressed.Based on the investigation, no systemic issue or deficiency was identified for the architect total b-hcg reagent lot 15730ui00.

• 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: 11227376
• Report Number: 3005094123-2021-00012
• Device Sequence Number: 3512364
• Product Code: DHA
• UDI-Device Identifier: 00380740014971
• UDI-Public: 00380740014971
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K983424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

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: 06/10/2021
• Device Model Number: 7K78-30
• Device Catalogue Number: 07K78-30
• Device Lot Number: 15730UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 02/26/2021
• 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 SR REFURB (JPN), 03M74-99, ISR02238; ARC SR REFURB (JPN), 03M74-99, ISR02238