MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C8000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	01G06-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 - patient identifier: sids = (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated magnesium results generated on the architect c8000 processing module for two patients.The customer is using a non-abbott magnesium reagent.The field service representative (fsr) went onsite to inspect the instrument.The samples were repeated after the repair and the results were normal.The following data was provided: customer¿s normal range: < 1.02 mmol/l sid (b)(6) initial result = >10 mmol/l, repeat result post repair = 0.76 mmol/l sid (b)(6) initial result = >2 mmol/l, repeat result post repair = 0.87 mmol/l there was no impact to patient management reported.
Additional Manufacturer Narrative
The technical support specialist (tss) inspected the instrument, performed extensive troubleshooting and replaced multiple parts.Ultimately, the tss resolved the issue by calibrating the reagent probe (r1) positioning.No additional discrepant result issues have been reported since the service activity was completed.The reagent probe was determined to be the likely cause of the issue.An instrument service history review for (b)(6) revealed no additional service tickets associated with discrepant/erratic patient 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 of the clinical chemistry systems did not identify any trends related to the architect system, likely cause part, or discrepant results as described in this complaint.The device history records were reviewed, and no non-conformances or deviations were identified.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the architect c8000 processing module for serial number (b)(6) or the reagent probe were identified.
Event or Problem Description
The customer observed falsely elevated magnesium results generated on the architect c8000 processing module for two patients.The customer is using a non-abbott magnesium reagent.The field service representative (fsr) went onsite to inspect the instrument.The samples were repeated after the repair and the results were normal.The following data was provided: customer¿s normal range: < 1.02 mmol/l.Sid (b)(6) initial result = >10 mmol/l, repeat result post repair = 0.76 mmol/l.Sid (b)(6) initial result = >2 mmol/l, repeat result post repair = 0.87 mmol/l.There was no impact to patient management reported.

• Brand Name: ARCHITECT C8000
• 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: 19418153
• Report Number: 3016438761-2024-00323
• Device Sequence Number: 15640285
• Product Code: JJE
• UDI-Device Identifier: 00380740023089
• UDI-Public: (01)00380740023089
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 06/17/2024

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: 01G06-01
• 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: 05/14/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 06/17/2024
• 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: NON-ABBOTT REAGENT, 01-NON ABBOTT RGT.; NON-ABBOTT REAGENT, 01-NON ABBOTT RGT.
• Patient Sex: Unknown