MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT TOTAL B-HCG

Catalog Number 07K78-25

Device Problem False Negative Result (1225)

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

Event Date 09/16/2019

Event Type  malfunction  

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.Patient identifier: (b)(6).

Event Description

The customer reported false negative architect total b-hcg results on two pregnant female patients.Results provided: (b)(6) 2019 sid (b)(6) = less than 1.2/less than 1.2 miu/ml; (b)(6) 2019 sid (b)(6) = less than 1.2/less than 1.2 miu/ml.No impact to patient management was reported.

Manufacturer Narrative

A review of complaints determined that there are no trends for the product list 7k78 for the complaint issue.Return testing was not completed as returns were not available.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, accuracy of the architect total b-hcg assay has been evaluated with a retained in-house kit of the same lot# 04522ui00 and met all specifications, confirming that this lot is meeting the architect total b-hcg product requirements.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 lot# 04522ui00.

• Brand Name: ARCHITECT TOTAL B-HCG
• Type of Device: B-HCG
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 9162965
• MDR Text Key: 219197593
• Report Number: 3005094123-2019-00280
• 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: 11/29/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2020
• Device Catalogue Number: 07K78-25
• Device Lot Number: 04522UI00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 11/28/2019
• Supplement Dates FDA Received: 11/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR ANALYZER LIST 01L86-01; ARCHITECT I1000SR ANALYZER LIST 01L86-01; SERIAL (B)(6); SERIAL (B)(6)