MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT B12 REAGENT KIT; RADIOASSAY, VITAMIN B12

Catalog Number	07K61-37
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported doctors questioning falsely high architect vitamin b12 results for multiple patient samples.The customer stated high results of > 2000 pg/ml were being generated across 2 of their analyzers.The customer sent the samples out to another lab (reference lab) and the b12 result of one sample came back as 285 pg/ml.The customer¿s reference range for b12 is 213-816 pg/ml.There was no impact to patient management reported.
Additional 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.
Additional Manufacturer Narrative
Section d4 expiration date and primary udi number was updated.The complaint investigation 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.Return testing was not completed as returns were not available.A search for similar complaints did not identify an increase in complaint activity for lot 62127ud00.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 lot number 62127ud00 and complaint issue.In-house accuracy testing was completed with complaint lot number 62127ud00.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 vitamin b12 for lot 21075ui01 was identified.
Event or Problem Description
The customer reported doctors questioning falsely high architect vitamin b12 results for multiple patient samples.The customer stated high results of 2000 pg/ml were being generated across 2 of their analyzers.The customer sent the samples out to another lab (reference lab) and the b12 result of one sample came back as 285 pg/ml.The customer¿s reference range for b12 is 213-816 pg/ml.There was no impact to patient management reported.

• Brand Name: ARCHITECT B12 REAGENT KIT
• Common Device Name: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 20600937
• Report Number: 3005094123-2024-00573
• Device Sequence Number: 8787519
• Product Code: CDD
• UDI-Device Identifier: 00380740014193
• UDI-Public: (01)00380740014193(17)250318(10)59441UD00
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/06/2025

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: 03/18/2025
• Device Catalogue Number: 07K61-37
• Device Lot Number: 62127UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2024
• 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, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Sex: Unknown