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 08/23/2022

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 reported a falsely elevated magnesium result generated on the architect c4000 analyzer on a patient.Results provided: (b)(6) 2022, sid (b)(6) = 4.3 / 1.3 mg/dl, another architect = 1.4 mg/dl.(normal range - 1.6 - 2.6 mg/dl).No impact to patient management was reported.

Manufacturer Narrative

The field service representative (fsr) inspected the instrument and performed multiple troubleshooting procedures including part replacement.Return testing was not completed as returns were not available.A review of tickets determined there is normal complaint activity for lot number 80593un21.Trending review did not identify any trends for the issue for the product.Labeling was reviewed and found to be adequate.Historical performance of magnesium reagent lot number 80593un21 was evaluated using worldwide data from abbottlink.The median patient population result for lot 80593un21 is within the established control limits and confirms no systemic issue for the lot.Based on our investigation, no systemic issue or deficiency with architect magnesium reagent ln 3p68-22(lot number 80593un21) was identified.

• 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: 15436908
• MDR Text Key: 300572428
• Report Number: 3002809144-2022-00328
• 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: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2023
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 80593UN21
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2022
• 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, C402770; ARC C4000 INTGR, 02P24-40, C402770