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	10/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included, no additional patient information was available.This follow-up submission is being send for additional information received on24nov2024; the likely cause product has been changed from magnesium reagent, list # 03p68-24 to architect c4000 processing module, list number 02p24-01.The field service representative (fsr) inspected the architect c4000 processing module, performed troubleshooting and during troubleshooting, the fsr determined the arc c8k cuv pr 1 pair the likely cause of the issue and cleaned the cuvette.Cleaning of the part resolved the issue.No additional discrepant result issues have been reported since the service activity was completed.A review of tracking and trending of the architect c4000 processing module and arc c8k cuv pr 1 pair did not identify any trends associated with the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.A review of the clinical chemistry systems revealed found no systemic issues or trends for the issue associated with this ticket (erratic/discrepant results).Based on the investigation, no systemic issue or deficiency of the architect c4000 processing module, sn (b)(6) was identified.
Event or Problem Description
The customer observed falsely elevated magnesium flier on an architect c4000 processing module for a patient.Results were not reported to the medical provider.The following patient data was provided by the customer.The customer is not able to provide the sample id# nor the reference range.Initial magnesium result = 2.88 mmol/l, repeat from another analyzer= 0.9 mmol/l, repeat on this instrument: 0.88, 0.88 mmol/l.No impact to patient management was reported.

• 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: 20895647
• Report Number: 3016438761-2024-00705
• Device Sequence Number: 7716143
• Product Code: JJE
• UDI-Device Identifier: 00380740003746
• UDI-Public: (01)00380740003746
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2024

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: 11/24/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2013
• 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 C8K CUV PR 1 PAIR, 01G46-02,; CC MAGNESIUM (1000T), 03P68-24, 64202UD00
• Patient Sex: Unknown