MAUDE Adverse Event Report: A.I.D.D LONGFORD MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Catalog Number 08P19-25

Device Problem High Test Results (2457)

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

Event Date 05/04/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer stated that a falsely elevated alinity c magnesium result of 8.685 mg/dl was generated for patient sample id (b)(6) on (b)(6) 2021.Repeat testing was requested.The same sample retested at 1.927, 1.927, 1.902, 1.927, 1.923 and 1.894 mg/dl.The customer's normal range is 1.6 to 2.6 mg/dl.No adverse impact to patient management was reported.

Manufacturer Narrative

A review of historical quality data determined that there is normal complaint activity for lot 26090ud00.Trending review determined no adverse or non-statistical trend.Labeling is adequate and provides specific instructions to the customer regarding the current issue.Based on the available information, no product deficiency was identified.

• Brand Name: MAGNESIUM
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 11872657
• MDR Text Key: 252390453
• Report Number: 3005094123-2021-00100
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740176525
• UDI-Public: 00380740176525
• Combination Product (y/n): N
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2022
• Device Catalogue Number: 08P19-25
• Device Lot Number: 26090UD00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC01802