MAUDE Adverse Event Report: ABBOTT GMBH MAGNESIUM

Model Number	03P6822
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided.
Event or Problem Description
The customer observed 2 falsely elevated architect magnesium results.No adverse impact to patient management was reported.Sid (b)(6): initial result of >9.5 mg/dl retested at 1.94 and 1.95 mg/dl.Sid (b)(6): initial result of 5.38 mg/dl retested at 9.7 mg/dl (1:5 dilution) and 1.82 mg/dl.
Additional Manufacturer Narrative
Upon further review of the complaint on (b)(6) 2020, it was discovered that the initial report did not include the evaluation summary of the suspect medical device even though the evaluation had been completed at that time.This follow-up is being submitted to provide the omitted device evaluation conclusion.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 product.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.

• Brand Name: MAGNESIUM
• Common Device Name: MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10298887
• Report Number: 3002809144-2020-00711
• Device Sequence Number: 2496499
• 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,Followup
• Report Date (Section B): 09/16/2020

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
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 09/16/2020
• 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 C8000 SYSTEM, LIST 01G06-11; ARCHITECT C8000 SYSTEM, LIST 01G06-11; SERIAL (B)(6); SERIAL (B)(6)