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

Catalog Number 07P67-32

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

Completed information for section a1 patient identifier: sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 7p67-32 has a similar product distributed in the us, list number 7p67-21/-31.

Event Description

The customer observed falsely elevated alinity i b12 results for one sample.The following data was provided: on b)(6) 2024 sid (b)(6) initial result = 400 pmol/l, repeats = 288 pmol/l, 188 pmol/l, 211 pmol/l, 247 pmol/l, and 278 pmol/l no impact to patient management was reported.

Manufacturer Narrative

Section d4 primary udi number was updated from (b)(4) to (b)(4).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 field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A search for similar complaints did not identify an increase in complaint activity.Ticket 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 56198ud00 and the complaint issue.The overall performance of the alinity i b12 was reviewed using field data from customers worldwide.Review shows that the median patient results for lot 56198ud00 is comparable with other lots in the field confirming no systemic issue for the lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i b12 reagent for lot 56198ud00 was identified.

Event Description

The customer observed falsely elevated alinity i b12 results for one sample.The following data was provided: 11jan2024 sid (b)(6) initial result = 400 pmol/l, repeats = 288 pmol/l, 188 pmol/l, 211 pmol/l, 247 pmol/l, and 278 pmol/l.No impact to patient management was reported.

• Brand Name: ALINITY I B12 REAGENT KIT
• Type of Device: 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: 18584113
• MDR Text Key: 334384103
• Report Number: 3005094123-2024-00034
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 00380740131418
• UDI-Public: (01)00380740131418(17)240813(10)56198UD00
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K121314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 07P67-32
• Device Lot Number: 56198UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI20279; ALNTY I PROCESSING MODU, 03R65-01, AI20279