MAUDE Adverse Event Report: AXIS-SHIELD DIAGNOSTICS, LTD. AXIS SHIELD ACTIVE-B12 EIA; RADIOASSAY, VITAMIN B12

Model Number	FMABT100
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Confirmed with customer that they have no affected test kit remaining to return.
Event or Problem Description
Axis-shield diagnostics ltd.Received notification of a complaint on (b)(6) 2024 stating the customer had experienced out of range results, relating to the high and low controls reporting results out of range, when using fmabt100 lot 902959842.There was no impact to patient.The customer had an additional lot that did not display the same error and was able to proceed with testing.
Additional Manufacturer Narrative
The root cause was identified as a line clearance failure during the packing operation for fmabt100 902959842.Specifically, the labelling activity for the low and high control vials was performed in the same work zone, at the same time, leading to mislabelling of the controls.The root cause for this capa is therefore assigned to method - inadequate controls.
Event or Problem Description
Axis-shield diagnostics ltd.Received notification of a complaint on 19th june 2024 stating the customer had experienced out of range results, relating to the high and low controls reporting results out of range, when using fmabt100 lot 902959842.There was no impact to patient.The customer had an additional lot that did not display the same error and was able to proceed with testing.

• Brand Name: AXIS SHIELD ACTIVE-B12 EIA
• Common Device Name: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): AXIS-SHIELD DIAGNOSTICS, LTD.; luna place technology park; scotland, gb; dundee DD2 1 XA; GB DD2 1XA
• Manufacturer (Section G): AXIS-SHIELD DIAGNOSTICS, LTD.; luna place technology park; dundee DD2 1 XA; GB DD2 1XA
• Manufacturer Contact: claire dora ; luna place technology park; scotland, gb; dundee DD2 1-XA ; GB DD2 1XA ; 1382422000232
• MDR Report Key: 19760113
• Report Number: 8032314-2024-00001
• Device Sequence Number: 8875077
• Product Code: CDD
• UDI-Device Identifier: 05055845400046
• UDI-Public: 05055845400046
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: K121946
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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: 05/12/2025
• Device Model Number: FMABT100
• Device Catalogue Number: FMABT100
• Device Lot Number: 902959842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: YES - 2 CORRECTIVE ACTIO
• Patient Sequence Number: 1
• Patient Sex: Unknown