MAUDE Adverse Event Report: ABBOTT GMBH MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Model Number 03P6822

Device Problem High Test Results (2457)

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

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated magnesium results generated on the architect c4000 instrument for one patient.Sid (b)(4) generated an initial magnesium result of 2.47 mmol/l, repeated 1.0 mmol/l and 1.01 mmol/l.The discrepant result was not reported out of the lab.No impact to patient management was reported.

Manufacturer Narrative

A review of tracking and trending did not identify any trends for the complaint issue.Device history record review did not identify any issues associated with the customer¿s observation.Return testing was not completed as returns were not available.File sample testing was not performed as part of troubleshooting, the sample was retested with a lower normal result.Additionally, the issue has been resolved by service visit indicating the assay is performing as expected.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the magnesium reagent was identified.

• Brand Name: MAGNESIUM
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12150094
• MDR Text Key: 276199172
• Report Number: 3002809144-2021-00419
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (y/n): N
• PMA/PMN Number: K181748
• 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: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, (B)(4); ARC C4000 INTGR, 02P24-40, (B)(4)