MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C4000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	02P24-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
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 false elevated magnesium generated from an architect c4000 analyzer and provided the following data: normal patient range 1.6 ¿ 2.6 mg/dl.On (b)(6) 2024, sample id (b)(6), initial result was 2.31.The customer has a rule to repeat results > 2.Repeat result was 6.07.Repeat result on another analyzer (sn: (b)(6) was 1.9.Per the customer the discrepant result was not reported out to the patient¿s medical provider.There was no reported impact to patient management.
Event or Problem Description
The customer reported false elevated magnesium generated from an architect c4000 analyzer and provided the following data: normal patient range 1.6 ¿ 2.6 mg/dl.On (b)(6)2024, sample id (b)(6), initial result was 2.31.The customer has a rule to repeat results > 2.Repeat result was 6.07.Repeat result on another analyzer (sn: (b)(6) was 1.9.Per the customer the discrepant result was not reported out to the patient¿s medical provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
The architect c4000 for serial (b)(6) was inspected and it was determined that cleaning the cuvettes and part replacement was required.The issue was resolved by replacing the arc c4 cuvt seg.No additional discrepant result issues have been reported since the service activity was completed.Return testing was not completed as returns were not available.The instrument service history review for (b)(6) revealed no additional service tickets associated with discrepant/erratic results.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of tracking and trending for the architect c4000 did not identify any trends.A review of tracking and trending for the arc c4 cuvt seg did not identify any trends.Review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect c4000 for serial (b)(6) or the arc c4 cuvt seg were identified.

• Brand Name: ARCHITECT C4000
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 20905388
• Report Number: 3016438761-2024-00718
• Device Sequence Number: 9181014
• Product Code: JJE
• UDI-Device Identifier: 00380740003746
• UDI-Public: (01)00380740003746
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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 Catalogue Number: 02P24-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2017
• 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: CC MAGNESIUM (1000T), 03P68-24, (B)(6); CC MAGNESIUM (1000T), 03P68-24, (B)(6)
• Patient Sex: Unknown