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	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no additional patient information provided by the customer.A review of tickets determined that there is normal complaint activity for magnesium, lot 64034un20.Trending review determined no trends for falsely elevated results for the product.Return testing was not completed as returns were not available.A repeat test on the patient samples at the customer site produced an acceptable result.Historical performance of lot number 64034un20 was evaluated using world wide data from abbottlink.The evaluation indicated that the patient median result for the lot is within the established control limits.Therefore, no unusual reagent lot performance was identified.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 magnesium reagent, lot 64034un20 was identified.
Event or Problem Description
The customer reported falsely elevated magnesium results on one patient generated on the architect analyzer.The results provided were: on (b)(6) 2020 sid (b)(6) initial = 8.09mg/dl (1.6 - 2.6mg/dl); 2.02mg/dl.There was no reported impact to patient management.

• Brand Name: MAGNESIUM
• Common Device Name: MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10327027
• Report Number: 3002809144-2020-00735
• Device Sequence Number: 11565593
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2020

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: 04/09/2021
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 64034UN20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1