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

Catalog Number 07K78-77

Device Problem False Negative Result (1225)

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

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.No patient identifier information is available.Facility name was truncated.Full facility name is (b)(6).

Event Description

The customer generated a falsely negative architect total b-hcg result for one patient.The initial result was <1.2 miu/ml (negative), repeated as 31 miu/ml (postivie) and when tested by another analyzer the result was 25.83 miu/ml (positive).The sample was retested on another platform (beckman) and the result was 26.89 (positive).The clinical physician was skeptical of relevant results.The patient is a 52 year old woman with a mass in the pelvic cavity.No impact to patient management was reported.

Manufacturer Narrative

This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

Manufacturer Narrative

H6 health effect impact code: f26.Component code: g01003.D8 was this device serviced by a third party? no.A review of tickets was performed for reagent lot number 11237ui02.The ticket search determined that there is normal complaint activity for the reagent lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A retained reagent kit of lot number 11237ui02 was tested.All validity and acceptance criteria were met during completion of the protocol, demonstrating that the lot is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Review of labeling also supported that the customer's reported use of the product was not in alignment with product labeling.Based on the investigation no systemic issue or deficiency of the architect total hcg reagent lot 11237ui02 was identified.

• 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: 11167719
• MDR Text Key: 251187591
• Report Number: 3005094123-2021-00008
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2021
• Device Catalogue Number: 07K78-77
• Device Lot Number: 11237UI02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR52319; ARC I2000SR INST, 03M74-02, ISR52319; ARC I2000SR INST, 03M74-02, ISR52319