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

Model Number	03P6832
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: MAGNESIUM
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 9936441
• Report Number: 3016438761-2020-00029
• Device Sequence Number: 2827657
• Product Code: JGJ
• UDI-Device Identifier: 00380740161637
• UDI-Public: 00380740161637
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/10/2020
• 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: ARCHITECT C16000 SYSTEM.; ARCHITECT C16000 SYSTEM.; LIST (B)(4), SERIAL (B)(6).; LIST (B)(4), SERIAL (B)(6).