MAUDE Adverse Event Report: ABBOTT GMBH MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Model Number 03P6822

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2023

Event Type  malfunction  

Event Description

The customer observed falsely elevated magnesium results generated on the architect c4000 processing module for one sample that was not released out of the lab.The following results were provided: sid (b)(6) original result = 7.5 mg/dl, rerun result on another architect = 1.9 mg/dl no impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Completed information for section a1 patient identification: sids(b)(6) all available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely elevated magnesium results generated on the architect c4000 processing module for one sample that was not released out of the lab.The following results were provided: sid (b)(6)original result = 7.5 mg/dl, rerun result on another architect = 1.9 mg/dl no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false elevated magnesium results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.Instrument troubleshooting including cleaning the cuvettes, rebuilding reagent and sample syringes, and other adjustments/replacements were performed.Trending review did not identify any trends for the issue for the product.The device history record review did not identify any non-conformances or deviations with lot number 27365un22 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency with the magnesium assay for lot 27365un22 was identified.All available patient information was included.Additional patient details are not available.

• Brand Name: MAGNESIUM
• Type of Device: PHOTOMETRIC METHOD, 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17265847
• MDR Text Key: 318786010
• Report Number: 3002809144-2023-00300
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181748
• 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,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2023
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 27365UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, C402248; ARC C4000 INTGR, 02P24-40, C402248