MAUDE Adverse Event Report: A.I.D.D LONGFORD 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 11/24/2022

Event Type  malfunction  

Event Description

The customer observed falsely elevated alinity i b12 results for one patient that required corrected reports.Additionally, the customer noted that controls were out of specification.The following data was provided (customer reference range is 153 to 755 pmol/l): sample id (b)(6) released result 237 pmol/l, corrected result 141.0 pmol/l.No impact to patient management was reported.

Manufacturer Narrative

Complete information from patient identifier: sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Data and information provided by the customer confirms the complaint issue without indication for any additional issue identified.The ticket search by lot number indicates the product lot is performing as expected.Return testing was not performed as returns were not available.Device history record review was performed on lot 41679ud00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the product for the issue.Review of field data for the alinity i vitaminb12 assays shows that the median patient result for lot 41679ud00 falls within 1sd of the established baseline, indicating the reagent lot is performing acceptably on market.A review of the labeling addresses the customer's issue.Based on the investigation, no systemic issue or deficiency of the architect anti-hcv reagent was identified.Corrected information for section b5: the customer observed falsely elevated alinity i b12 results for one patient that required corrected reports.Additionally, the customer noted that controls were out of specification.The following data was provided (customer reference range is 153 to 755 pmol/l): sample id (b)(6) released result 237 pmol/l, corrected result 141.0 pmol/l, sample id (b)(6) released result 271.600 pmol/l, corrected result 192.5 pmol/l, sample id (b)(6) released result 247.4 pmol/l, corrected result 190 mmol/l, sample id (b)(6) released result 245.8 pmol/l, corrected result 164.8 pmol/l, sample id (b)(6) released result 241 pmol/l, corrected result 182 pmol/l, sample id (b)(6) released result 274 pmol/l, corrected result 195 pmol/l, sample id (b)(6) released result 291 pmol/l, corrected result 221 pmol/l, sample id (b)(6) released result 314 pmol/l, corrected result 219 pmol/l.

• 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: 16038116
• MDR Text Key: 308373465
• Report Number: 3005094123-2022-00304
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/01/2023

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: 06/04/2023
• Device Catalogue Number: 07P67-32
• Device Lot Number: 41679UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• 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, AI22236; ALNTY I PROCESSING MODU, 03R65-01, AI22236