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 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 7p67-32 that has a similar product distributed in the us, list number 7p67-31.Initial reporter name and address: a leading zero was added to the field because the system requires a minimum of 5 digits in the postal code field.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed discrepant alinity i b12 results for a patient while running on the alinity i processing module.The following data was provided: sample id (b)(6).B12 results measured on (b)(6) 2021 = 140, 223, 86 pg/ml (this value was released).B12 results measured on (b)(6) g2021 = 97, 113, 124, 120, 90, 116, 109, 83, 104, 112 pg/ml.The customer¿s normal range is > 220 pg/ml.The customer is questioning the elevated result of 223 pg/ml as well as the imprecision of the b12 results generated.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for imprecise alinity i b12 results and potential false elevated result 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 ticket searches determined normal complaint activity for reagent lot 28132ud00.The trending review determined no trends were identified for the product for the issue.Accuracy testing was performed using an in-house retained kit of lot 28132ud00 stored at the recommended storage conditions.All validity and acceptance criteria were met indicating that the lot is performing acceptably.Device history record was reviewed and did not identify any non-conformances or deviations with the reagent lot number and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency for alinity i b12, reagent lot 28132ud00 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
• MDR Report Key: 12372346
• MDR Text Key: 268299303
• Report Number: 3005094123-2021-00159
• 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
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2022
• Device Catalogue Number: 07P67-32
• Device Lot Number: 28132UD00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• 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); ALNTY I PROCESSING MODU, 03R65-01, AI01977