MAUDE Adverse Event Report: ABBOTT GMBH MAGNESIUM

Model Number	03P6822
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier = (b)(6).A review of tickets determined that there is normal complaint activity for lot 74519un20.Trending review determined no adverse trend for false elevated results for the magnesium reagent.Return testing was not completed as returns were not available.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, lot number 74519un20 was identified.
Event or Problem Description
The customer reported false elevated architect magnesium results on one patient.The results provided were: on (b)(6) 2020 sid (b)(6) = >9.5 mg/dl, repeated 9.7, 1.82 mg/dl.No impact to patient management was reported.

• Brand Name: MAGNESIUM
• Common Device Name: MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10304556
• Report Number: 3002809144-2020-00713
• Device Sequence Number: 18999599
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 07/21/2020

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: 04/16/2021
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 74519UN20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1