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

Catalog Number 07P67-32

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/28/2022

Event Type  malfunction  

Event Description

The customer questioned alinity i b12 results for 2 patients.The customer uses the normal range > 200 pg/ml.The following was provided by the customer: patient id (b)(6) 2022 <83 pg/ml.(b)(6) 2022 129 pg/ml.(b)(6) 2022 88 pg/ml.(b)(6) 2022 184 pg/ml.The customer is unsure which result for each test date is correct and reported the mean between the two results.Patient id (b)(6) 2022 191 pg/ml.(b)(6) 2022 263 pg/ml.(b)(6) 2022 218 pg/ml.(b)(6) 2022 186 pg/ml.The customer is unsure which result for each test date is correct and reported the mean between the two results.On (b)(6) 2022, an additional patient was questioned by the customer: id (b)(6), initial result 198 pg/ml, repeated 551 pg/ml no impact to patient management was reported.

Manufacturer Narrative

Multiple patients were reported; refer to event for a summary of all sids and associated test results.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation for imprecise alinity i b12 result 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 testing of the complaint lot number.Trending review determined no related trend for the product.Return testing was not completed, as returns were not available.Accuracy testing was performed using an in-house retained kit of lot 34522ud00, stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Device history record review on lot number 34522ud00 did not identify any non-conformances or deviations with the likely cause lot.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity i b12, lot number 34522ud00, was identified.

• Brand Name: ALINITY I B12 REAGENT KIT
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 13937858
• MDR Text Key: 294153193
• Report Number: 3005094123-2022-00059
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2022
• Device Catalogue Number: 07P67-32
• Device Lot Number: 34522UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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)