MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) MAGNESIUM

Model Number 03P6832

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

No customer returns were available.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for the likely cause lot.Labeling was reviewed and found to be adequate.Based on the available information, no product deficiency was identified.

Event Description

The customer observed falsely elevated magnesium results: initial 11.66 mg/dl; repeat 1.8 mg/dl on the architect c16000 system.The customer's reference range is 1.6 to 2.6 mg/dl.There was no impact to patient management reported.

Manufacturer Narrative

This mdr was inadvertently submitted under the incorrect suspect medical device manufacturing site.The error was discovered on (b)(6) 2020.Mdr number 3002809144-2020-00461 was submitted to correct the manufacturing site from (b)(4) texas to (b)(4) germany.

• Brand Name: MAGNESIUM
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 9936441
• MDR Text Key: 197999620
• Report Number: 3016438761-2020-00029
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161637
• UDI-Public: 00380740161637
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

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: 10/24/2020
• Device Model Number: 03P6832
• Device Catalogue Number: 03P68-32
• Device Lot Number: 77040UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 06/08/2020
• Supplement Dates FDA Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000 SYSTEM.; ARCHITECT C16000 SYSTEM.; LIST (B)(4), SERIAL (B)(6).; LIST (B)(4), SERIAL (B)(6).