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

Model Number 7K78-25

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: no further patient information was provided.

Event Description

The customer obtained a false negative architect total b-hcg result for a female patient diagnosed with an ectopic pregnancy.The following results were provided: (b)(6) 2020 sample id (b)(6): 36.32 miu/ml.(b)(6) 2020 sample id (b)(6): <1.20 miu/ml.(b)(6) 2020 sample id (b)(6): 23.82 miu/ml.No impact to patient management was reported.

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 in house testing of retained kits with the complaint lot number.Return testing was not completed as returns were not available.Review of complaint activity and trending reports did not identify any issues or trends.Device history record review for the complaint lot did not identify any non-conformances or deviations.In house testing was performed using a retained kit of the complaint lot.All criteria were met indicating acceptable product performance.The overall performance of architect total b-hcg reagents in the field was reviewed using data gathered from customers worldwide.The median patient results of the positive population were within the acceptable, indicating the performance of the lot is acceptable.Based on our investigation, no systemic issue or deficiency of the architect total b-hcg reagent lot was identified.D4 expiration date changed from 01/25/2021 to 01/21/2021 due to an entry error.

• Brand Name: ARCHITECT TOTAL B-HCG REAGENT KIT
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 10895433
• MDR Text Key: 228358941
• Report Number: 3005094123-2020-00264
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: 00380740014964
• Combination Product (y/n): N
• PMA/PMN Number: K983424
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2021
• Device Model Number: 7K78-25
• Device Catalogue Number: 07K78-25
• Device Lot Number: 12124UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR MOD, 01L86-01, I1SR03859; ARC I1000SR MOD, 01L86-01, I1SR03859