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

Model Number	03P6832
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for architect magnesium reagent lot number 57754un20.Trending review determined no trends for discrepant patient results for the product.World wide data from abbott link was reviewed and determined that the patient median result for magnesium reagent lot number 57754un20 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 customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the architect magnesium reagent lot number 57754un20 was identified.Patient identifier complete sid: (b)(6).
Event or Problem Description
The customer reported a falsely elevated magnesium result generated on the architect c4000 analyzer on one patient.Results provided: (b)(6) 2020; (b)(6)= 7.4 / 1.78 mg/dl.Normal range: 1.6-2.6 mg/dl.No impact to patient management was reported.

• Brand Name: MAGNESIUM
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10726763
• Report Number: 3002809144-2020-01043
• Device Sequence Number: 3457136
• Product Code: JGJ
• UDI-Device Identifier: 00380740161637
• UDI-Public: 00380740161637
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181748
• 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): 10/23/2020

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: 06/25/2021
• Device Model Number: 03P6832
• Device Catalogue Number: 03P68-32
• Device Lot Number: 57754UN20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/23/2020
• 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: ARC C4000 INTGR, 02P24-40, C402250