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

Model Number 7K78-30

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2021

Event Type  malfunction  

Manufacturer Narrative

There was no further patient information provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false negative architect total b-hcg result on one patient.The results provided were: on 20jun2021 sid (b)(6) initial =<1.2 miu/ml (or=25.00 miu/ml=positive) there was no reported impact to patient management.

Manufacturer Narrative

The complaint evaluation 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 and in-house testing of architect total b-hcg reagent lot 21034ui00.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.The overall performance of architect total -hcg reagents in the field was reviewed using data gathered via abbottlink from customers worldwide and suggested that the performance of the lot is acceptable.Inhouse testing determined that the specificity performance is not negatively impacted.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect total b-hcg reagent lot 21034ui00.

• 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: 12160114
• MDR Text Key: 263459797
• Report Number: 3005094123-2021-00132
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00380740014971
• UDI-Public: 00380740014971
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR60755; ARC I2000SR INST, 03M74-02, ISR60755