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 10/03/2023

Event Type  malfunction  

Event Description

The customer reported imprecise alinity i b12 results.The customer provided the following data: unit of measure is pg/ml on (b)(6) 2023, sample id 9202 generated the following 5 results 176, 304, 207, 225, & 199 with lot 53664ud00.There was no reported impact to patient management.

Manufacturer Narrative

This report is being filed on an international product, list number 7p67-32 and there is a similar product distributed in the us, list number 7p67-21 / 31.All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

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.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Device history review did not identify any nonconformances, potential nonconformances or deviations associated with the likely cause lot number and complaint issue.The ticket search by lot did not identify an increase in complaint activity.Review of ticket and trending concluded that there no trends identified.In-house testing was conducted, which determined that the likely cause lot met acceptance and validity criteria for abbott controls and the product is performing as expected.Labeling was reviewed and sufficiently addresses the customer¿s reported issue.Based on the investigation, no systemic issue or deficiency was identified for the alinity i b12 reagent lot 53664ud00.

Event Description

The customer reported imprecise alinity i b12 results.The customer provided the following data: unit of measure is pg/ml on (b)(6) 2023, sample id (b)(6) generated the following 5 results 176, 304, 207, 225, & 199 with lot 53664ud00.There was no reported impact to patient management.

• 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: 18061055
• MDR Text Key: 327273750
• Report Number: 3005094123-2023-00296
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 12/18/2023

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 Expiration Date: 05/09/2024
• Device Catalogue Number: 07P67-32
• Device Lot Number: 53664UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2023
• 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, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)