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

Model Number 03P6832

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer stated that a falsely elevated architect magnesium result of 7.56 mg/dl retested at 2.38 and 2.31 mg/dl for patient sample id (b)(6).No adverse impact to patient management was reported.

Manufacturer Narrative

Upon retrospective review an error was identified with section d of this report: d3 (abbott laboratories (irving/iacc).The correct manufacturer location should be (abbott gmbh).This correction has been submitted in manufacturer report number 3002809144-2020-00453.Any future information regarding this event will be submitted under manufacturer report number 3002809144-2020-00453.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and instrument service.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The quality control (qc) results were reported to be acceptable.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.Technical bulletin (tb) 1041-2012 provides information about elevated magnesium patient results that may occur due to contamination from other sources of magnesium.Magnesium is found in multiple reagents and in architect csystem water bath additive and ict sample diluent.This tb contains troubleshooting information for magnesium issues that may be due to system specific conditions.Based on the investigation no product deficiency was identified for the magnesium reagent, lot 04426un19.

• 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: 9501418
• MDR Text Key: 219220034
• Report Number: 1628664-2019-00772
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161637
• UDI-Public: 00380740161637
• 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,Followup
• Report Date: 06/08/2020

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: 03/18/2020
• Device Model Number: 03P6832
• Device Catalogue Number: 03P68-22
• Device Lot Number: 04426UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 01/13/2020; 06/08/2020
• Supplement Dates FDA Received: 01/16/2020; 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 SYSTEM, LIST 02P24-01.; ARCHITECT C4000 SYSTEM.; ARCHITECT C4000 SYSTEM.; LN 02P24-01 SN (B)(6) .; LN 02P24-01 SN (B)(6). ; SN (B)(6) .