MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT B12 REAGENT KIT; RADIOASSAY, VITAMIN B12

Catalog Number 07K61-35

Device Problem High Test Results (2457)

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

Event Date 11/27/2022

Event Type  malfunction  

Manufacturer Narrative

The initial reporter postal code of (b)(6) should be (b)(6).A digit of 0 was added to align with form 5 digit format.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The account observed false elevated architect b12 that repeated lower.Sid: (b)(6) (36 year old pregnant patient with history of pet)) generated 767.6, 1213.2, 106.0, 100.3, 89.7, 103.6, 96.8, 101.2, 82.1 pmol/l.No additional specific patient information provided.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely elevated architect b12 results 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 in-house testing.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any nonconformances or deviations associated with the likely lot number 41672ud00 and complaint issue.In-house accuracy testing was completed with complaint lot number 41672ud00.Testing met validity and acceptance criteria and the product is performing as expected.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the architect b12 reagent for lot 41672ud00 was identified.

• Brand Name: ARCHITECT B12 REAGENT KIT
• Type of Device: RADIOASSAY, VITAMIN B12
• 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 ; EI N39 E932 ; 433331157
• MDR Report Key: 16019933
• MDR Text Key: 308528089
• Report Number: 3005094123-2022-00299
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121314
• 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
• Report Date: 02/24/2023

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: 06/04/2023
• Device Catalogue Number: 07K61-35
• Device Lot Number: 41672UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 02/22/2023
• Supplement Dates FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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, ISR51760; ARC I2000SR INST, 03M74-02, ISR51760
• Patient Age: 36 YR
• Patient Sex: Female