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 Consequences Or Impact To Patient (2199)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: multiple = sid (b)(6).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 on one patient.The results provided were: on (b)(6) 2020; sid (b)(6) generated initial result of 262 miu/ml (positive) (customer reference range normal <100 miu/ml); a new sample was drawn sid (b)(6), and generated result of 1.20 miu/ml (negative), repeated 1.82 miu/ml (negative).The patient stated that her last menstruation was on (b)(6) 2020.No impact to patient management was 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, labelling review, device history record review, field data review and inhouse testing of retained kits with the complaint lot number.Return testing was not completed as returns were not available.Review of tracking and trending reports did not identify any related trends for the issue for the product.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Labeling was reviewed and found to adequately address the issue under review.An in-house testing protocol was completed for the complaint lot.All validity and acceptance criteria were met during completion of the protocol, demonstrating that the lot is performing acceptably.The overall performance of architect total b-hcg reagents was reviewed using worldwide field data and suggested that the performance of the lot is acceptable.Based on the investigation, no systemic issue or deficiency of the architect total b-hcg reagent lot was identified.

• 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: 10628988
• Report Number: 3005094123-2020-00222
• Device Sequence Number: 2605057
• Product Code: DHA
• UDI-Device Identifier: 00380740014971
• UDI-Public: 00380740014971
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 12/15/2020

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: 01/06/2021
• Device Model Number: 7K78-30
• Device Catalogue Number: 07K78-30
• Device Lot Number: 11237UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 12/15/2020
• 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, ISR08468; ARC I2K PROC MOD, 03M74-01, ISR08468; ARC I2K PROC MOD, 03M74-01, ISR08468