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

Catalog Number	08P19-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 11872657
• Report Number: 3005094123-2021-00100
• Device Sequence Number: 11853988
• Product Code: JGJ
• UDI-Device Identifier: 00380740176525
• UDI-Public: 00380740176525
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2022
• Device Catalogue Number: 08P19-25
• Device Lot Number: 26090UD00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY C PROCESSING MODU, 03R67-01, AC01802