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

Model Number	7K61-27
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated architect b12 result for one patient.The sample was automatically repeated by the instrument which generated a lower result.The following data was provided: on (b)(6) 2022 initial result = > 2000 pg/ml, repeat result = 107 pg/ml the customer reported the 107 pg/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated architect b12 result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.In-house testing of retained reagent kit was also completed.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.Ticket search by lot indicates that the reagent lot performs as expected for this product.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot number 37333ud00 and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.In-house testing of a retained reagent kit of the complaint lot was performed.Testing met acceptance criteria which indicates the product is performing as expected.Based on this investigation, no systemic issue or deficiency with the architect b12 reagent, lot number 37333ud00 was identified.

• Brand Name: ARCHITECT B12 REAGENT KIT
• Common Device Name: 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: 15492108
• Report Number: 3005094123-2022-00207
• Device Sequence Number: 1958036
• Product Code: CDD
• UDI-Device Identifier: 00380740014179
• UDI-Public: 00380740014179
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2023
• Device Model Number: 7K61-27
• Device Catalogue Number: 07K61-27
• Device Lot Number: 37333UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I1000SR INTGR, 01L86-40, (B)(6); ARC I1000SR INTGR, 01L86-40, (B)(6)
• Patient Sex: Unknown