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

Model Number 03P6832

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.Full sid (b)(6).No additional patient information available.

Event Description

The customer generated falsely elevated magnesium results for 1 patient on the architect c4000 processing module.The following information was provided: sid (b)(6) run on (b)(6) 2020, initial 9.02 mg/dl, repeat 2.6 mg/dl.2.6 mg/dl was reported out of the lab.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets was performed for reagent lot number 11805un20.The ticket search determined that there is normal complaint activity for the reagent lot.A review of tracking and trending did not identify any trends for the complaint issue.Worldwide field data was reviewed and determined that the patient median result for magnesium reagent lot number 11805un20 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 complaint issue.Based on the investigation, no systemic issue or deficiency of the architect magnesium reagent lot number 11805un20 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: 10896596
• MDR Text Key: 241306444
• Report Number: 3002809144-2020-01138
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161637
• UDI-Public: 00380740161637
• Combination Product (y/n): N
• PMA/PMN Number: K181748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2021
• Device Model Number: 03P6832
• Device Catalogue Number: 03P68-32
• Device Lot Number: 11805UN20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, C402839; ARC C4000 INTGR, 02P24-40, C402839