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

Catalog Number 03P68-24

Device Problem High Test Results (2457)

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

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.Patient identifier complete sid: (b)(6).

Event Description

The customer reported a falsely increased magnesium (mg) result generated on the architect c16000 analyzer on a patient.Results provided: (b)(6) 2021 sid (b)(6) = 3.57 / 0.71 mmol/l.Normal range: 0.66-1.07 mmol/l.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for architect magnesium reagent lot number 26080ud00.Trending review determined no trends for discrepant patient results for the product.Worldwide data from abbottlink was reviewed and determined that the patient median result for the magnesium reagent lot number 26080ud00 is within established control limits.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the architect magnesium reagent lot number 26080ud00 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: 12342291
• MDR Text Key: 267264814
• Report Number: 3005094123-2021-00153
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740169855
• UDI-Public: 00380740169855
• 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: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• 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: 03P68-24
• Device Lot Number: 26080UD00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C16K PRC MOD, 03L77-01, C1600722; ARC C16K PRC MOD, 03L77-01, C1600722; ARC C16K PRC MOD, 03L77-01, C1600722