MAUDE Adverse Event Report: ABBOTT GMBH CLINICAL CHEMISTRY MAGNESIUM

Model Number 03P6822

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

This issue was previously reported under mdr number 1628664-2019-00772, for which an error was identified with the manufacturer name abbott laboratories (b)(4).This mdr is being submitted to correct the manufacturer name to abbott (b)(4).All available patient information has been included.No additional patient details are available.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 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) 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.

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.

• Brand Name: CLINICAL CHEMISTRY MAGNESIUM
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 10131105
• MDR Text Key: 196013460
• Report Number: 3002809144-2020-00453
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• 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: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 04426UN19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1