MAUDE Adverse Event Report: ABBOTT GMBH MAGNESIUM

Model Number 03P6822

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2020

Event Type  malfunction  

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 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.

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
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10298887
• MDR Text Key: 199744894
• Report Number: 3002809144-2020-00711
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000 SYSTEM, LIST 01G06-11; ARCHITECT C8000 SYSTEM, LIST 01G06-11; SERIAL (B)(6); SERIAL (B)(6)