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

Model Number	7K61-37
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2020
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a falsely elevated architect b12 result for one patient.The following data was provided (customer¿s reference range is 211-911 pg/ml): patient # initial result, on (b)(6) 2020, was 240, repeats were 197 and 160 pg/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated architect b12 results included a search for similar complaints, and the review of complaint text, trending data, labeling, device history records.Trending review determined no related trend for the product.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Device history record review on lot number 12324ui00 did not identify any non-conformances or deviations with the likely cause lot.Return testing was not completed, as returns were not available.Labeling was reviewed and found to adequately address the issue under review.The overall performance of architect b12 reagents in the field was reviewed using data gathered via abbottlink from customers worldwide and suggested that the performance is acceptable.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of architect b12, lot number 12324ui00, 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
• MDR Report Key: 10951364
• Report Number: 3005094123-2020-00273
• Device Sequence Number: 3189423
• Product Code: CDD
• UDI-Device Identifier: 00380740014193
• UDI-Public: 00380740014193
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121314
• Number of Events Summarized: 1
• Summary Report (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): 02/18/2021

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: 12/06/2020
• Device Model Number: 7K61-37
• Device Catalogue Number: 07K61-37
• Device Lot Number: 12324UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 02/18/2021
• 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, ISR51357; ARC I2000SR INST, 03M74-02, ISR51357