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 12/09/2021

Event Type  malfunction  

Manufacturer Narrative

Postal code: a leading zero was added to the field because the system requires a minimum of 5 digits in the postal code field.This report is being filed on an international product, list number 07p67-32 that has a similar product distributed in the us, list number 07p67-21/-31.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer obtained discrepant alinity i b12 results for a patient.The following results were provided (customer normal range: 220 pg/ml) sid (b)(4) measured on (b)(6) 2021 in pg/ml: at 2:23 pm = 150.At 3:50 pm = 247.At 4:36 pm = 210.At 5:47 pm = 319.The customer is unsure which results are the correct results.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for imprecise/aberrant alinity i b12 results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.The complaint activity review determined normal complaint activity for the reagent lot.Tracking and trending was reviewed and did not identify any related trends.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit of the complaint lot 30472ud00 stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.The device history records were reviewed and did not identify any non-conformances or deviations associated with the reagent lot and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for alinity i b12 reagent lot 30472ud00 was identified.G1 all manufacturers: g1 - contact information has been updated to included new contact name, email, address, phone number, and fax number.

• 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, IL N39 E-932 ; EI N39 E932 ; 2246682940
• MDR Report Key: 13043850
• MDR Text Key: 284799916
• Report Number: 3005094123-2021-00249
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 03/10/2022

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: 06/06/2022
• Device Catalogue Number: 07P67-32
• Device Lot Number: 30472UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 03/04/2022
• Supplement Dates FDA Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• 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)