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	08/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated creatinine on the architect c8000 processing module for one patient.The following results were provided (reference range 0.72 - 1.25 mg/dl): initial creatinine result= 14 mg/dl; repeat result= 0.71 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument and found the tubing, peristaltic head (rohs) was leaking.The fsr replaced the tubing, peristaltic head (rohs), which resolved the issue.Return testing was not completed as returns were not available.The instrument service history review revealed no additional 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 architect c8000 did not identify any trends associated with the complaint issue.A review of tracking and trending for the tubing, peristaltic head (rohs) did not identify any trends.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect c8000 processing module for serial (b)(6) or the tubing, peristaltic head (rohs), was identified.
Event or Problem Description
The customer observed a falsely elevated creatinine on the architect c8000 processing module for one patient.The following results were provided (reference range 0.72 - 1.25 mg/dl): initial creatinine result= 14 mg/dl; repeat result= 0.71 mg/dl.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: 20127653
• Report Number: 3016438761-2024-00512
• Device Sequence Number: 3227103
• Product Code: JJE
• UDI-Device Identifier: 00380740023089
• UDI-Public: (01)00380740023089
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/11/2024

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): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2014
• 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 CREATININE(7500T), 03L81-33, 77478UN23; CC CREATININE(7500T), 03L81-33, 77478UN23; TUBING, PERISTALTIC HEAD (ROHS), 7-35009685-04, UN
• Patient Sex: Unknown