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

Model Number	03P6822
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3002809144-2022-00328
• Device Sequence Number: 5673264
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2022

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
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC C4000 INTGR, 02P24-40, C402770; ARC C4000 INTGR, 02P24-40, C402770
• Patient Sex: Unknown