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

Catalog Number	03P68-24
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• 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: 11689468
• Report Number: 3005094123-2021-00068
• Device Sequence Number: 3508345
• Product Code: JGJ
• UDI-Device Identifier: 00380740169855
• UDI-Public: 00380740169855
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/02/2021

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: 06/08/2021
• Device Catalogue Number: 03P68-24
• Device Lot Number: 25900UD00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 06/02/2021
• 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: ARC C16K PRC MOD, 03L77-01, (B)(6); ARC C16K PRC MOD, 03L77-01, (B)(6)
• Patient Age: 60 YR