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 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

Was this device serviced by a third party? no.An evaluation is process.A followup report will be provided when the evaluation is complete.

Event Description

The account observed a false elevated architect magnesium of 3.7 mmol/l on a (b)(6) year old male patient who repeated 0.69 and 0.71 mmol/l when processing on the architect c16000.The account uses an adult magnesium reference range of 0.66 to 1.07 mmol/l.No race/ethnicity patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for lot 25900ud00.Trending review determined no adverse trend for falsely elevated results for the product.Return testing was not completed as returns were not available.Quality controls passed after maintenance was performed at the customer site and results were as expected.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.Analysis of the customer instrument logs shows multiple instances of error code 0550 in the days preceding the suspect sample magnesium result.Use error may have contributed to the customer¿s issue as incomplete sample processing or dirty cuvettes may cause erratic results on samples that follow.Based on the investigation, no systemic issue or product deficiency of the architect magnesium reagent, lot number 25900ud00 was identified.This follow-up is being submitted to include d8 and h6 information previously submitted using the h10 section in their respective fields.

• 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: 11689468
• MDR Text Key: 251206973
• Report Number: 3005094123-2021-00068
• 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: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2021
• Device Catalogue Number: 03P68-24
• Device Lot Number: 25900UD00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C16K PRC MOD, 03L77-01, (B)(6); ARC C16K PRC MOD, 03L77-01, (B)(6)
• Patient Age: 60 YR