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

Catalog Number 07K61-74

Device Problem Low Test Results (2458)

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

Event Date 06/30/2022

Event Type  malfunction  

Event Description

The customer observed falsely elevated architect b12 and architect folate results for a 70-year-old female patient.Architect b12 initial result 811 pmol/l (reference range: 138-652 pmol/l), mass spectrometry results b12 was <0.1 ng/ml no impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

This follow up is being submitted to include the initial coding in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.

Manufacturer Narrative

Data and information provided by the customer were reviewed and support the customers observation complaint issue without indication for any additional issue.The ticket searches determined normal complaint activity.Return testing was not performed as returns were not available.Device history record review was performed on lot 36008ud01, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the complaint issue.Labelling was reviewed which adequately addresses the current issue.Testing met acceptance and validity criteria and the product is performing as expected.Based on all reviewed data, we conclude that there is no product deficiency with the architect b12 reagent identified in this complaint.

• 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: 15297014
• MDR Text Key: 300565621
• Report Number: 3005094123-2022-00180
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 10/18/2022

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: 12/10/2022
• Device Catalogue Number: 07K61-74
• Device Lot Number: 36008UD01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/25/2022
• Supplement Dates Manufacturer Received: 09/06/2022; 10/10/2022
• Supplement Dates FDA Received: 09/27/2022; 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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, ISR64502.; ARC I2000SR INST, 03M74-02, ISR64502.; ARC I2000SR INST, 03M74-02, ISR64502.