MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) CLINICAL CHEMISTRY MAGNESIUM

Model Number 03P6822

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Manufacturing documentation was reviewed and no contributing factors to the complaint could be identified.Based on the available information, no product deficiency was identified.

Event Description

The customer stated that falsely elevated architect magnesium results were generated for two patients.No adverse impact to patient management was reported.Patient 1: initial result of 5.90 mg/dl retested at 1.9 mg/dl, sid (b)(6), tested on (b)(6) 2019.Patient 2: initial result of 6.0 mg/dl retested at 2.1 and 2.0 mg/dl, sid (b)(6), tested on (b)(6) 2019.

Manufacturer Narrative

This mdr was inadvertently submitted under the incorrect suspect medical device manufacturing site.The error was discovered on (b)(6) 2020.Mdr number 3002809144-2020-00460 was submitted to correct the manufacturing site from (b)(4) texas to (b)(4) germany.

• Brand Name: CLINICAL CHEMISTRY MAGNESIUM
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 9569685
• MDR Text Key: 219589885
• Report Number: 1628664-2020-00011
• 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: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 07588UN19
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER; ARCHITECT C4000 ANALYZER; LN 02P24-20 SN (B)(6); LN 02P24-20 SN (B)(6)