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	03/08/2022
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 results for multiple samples when compared to a reference laboratory.Additionally, the customer noted there was a shift in qc results starting on (b)(6) 2022.The following data was provided (customer¿s reference range: 211 to 1074 pg/ml, test date was (b)(6) 2022, units of measure is pg/ml): sid (b)(6) architect result = 315, arup result = 200.Sample 5: architect result = 360, arup result = 255.Sample 6: architect result = 383, arup result = 273.Sample 10: architect result = 405, arup result = 254.Sample 14: architect result = 371, arup result = 235.No impact to patient management was reported.
Additional 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, and 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 34043ud00 and complaint issue.In-house accuracy testing was completed with complaint lot number 34043ud00.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 34043ud00 was identified.
Event or Problem Description
The customer observed falsely elevated architect b12 results for multiple samples when compared to a reference laboratory.Additionally, the customer noted there was a shift in qc results starting on 03mar2022.The following data was provided (customer¿s reference range: 211 to 1074 pg/ml, test date was (b)(6) 2022, units of measure is pg/ml): sid (b)(6) initial result = 315, arup result = 200.Sample 5: initial result = 360, arup result = 255.Sample 6: initial result = 383, arup result = 273.Sample 10: initial result = 405, arup result = 254.Sample 14: initial result = 371, arup result = 235.No impact to patient management was reported.

• 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: 13978736
• Report Number: 3005094123-2022-00063
• Device Sequence Number: 5440258
• Product Code: CDD
• UDI-Device Identifier: 00380740014179
• UDI-Public: 00380740014179
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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: 09/27/2022
• Device Model Number: 7K61-27
• Device Catalogue Number: 07K61-27
• Device Lot Number: 34043UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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 I2000SR INST, 03M74-02, ISR62340; ARC I2000SR INST, 03M74-02, ISR62340
• Patient Sex: Unknown