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

Catalog Number 07K78-78

Device Problems False Positive Result (1227); High Test Results (2457)

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

Event Date 01/18/2022

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.Phone complete entry (b)(6).

Event Description

The customer observed a falsely elevated architect total b-hcg result for one patient.The following data was provided (customer¿s reference range is 0.0-5.0 miu/ml): initial result was 83.49, repeat was <1.20 miu/ml.There was no impact to patient management reported.

Manufacturer Narrative

Medical device problem code/a code corrected from a090809 to a090804.

Manufacturer Narrative

The complaint investigation for a falsely elevated architect total b-hcg result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review for the complaint lot.Trending review determined no related trend for the product.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Device history record review on lot number 27541ud03 did not identify any non-conformances or deviations with the likely cause lot.The overall performance of architect total b-hcg reagents in the field was reviewed using data gathered via abbott link from customers worldwide and suggested that the performance is acceptable.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of architect total b-hcg, lot number 27541ud03, 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
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; 433331157
• MDR Report Key: 13476868
• MDR Text Key: 291486442
• Report Number: 3005094123-2022-00025
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2022
• Device Catalogue Number: 07K78-78
• Device Lot Number: 27541UD03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)