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

Model Number	3L81-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely depressed creatinine result generated on the architect c8000 processing module for one patient with kidney failure.The following data was provided: initial result = 0.39 mg/dl, repeat = 15.75 mg/dl, repeat on another architect = 15.79 mg/dl no impact to patient management was reported.
Additional Manufacturer Narrative
Service inspected the analyzer and observed liquid on top of some of the cuvettes.Service cleaned the cuvettes manually as well as performed an automatic cuvette wash.A review of the service history for the analyzer identified no contributing factors and no subsequent issues related to the discrepant results.A review of tracking and trending data for the analyzer did not identify any systemic issues or trends.A review of trending and manufacturing data for the washer, cuvette (rohs) did not identify any trends or issues associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.No systemic or deficiency of the architect c8000 processing module was identified.After further evaluation, the suspect medical device was changed from creatinine, list 03l81-22, in section d of this report to architect c8000 analyzer, list 01g06-11.

• 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
• MDR Report Key: 12166290
• Report Number: 3016438761-2021-00253
• Device Sequence Number: 3840024
• Product Code: JJE
• UDI-Device Identifier: 00380740005979
• UDI-Public: 00380740005979
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 07/22/2021

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 Model Number: 3L81-22
• Device Catalogue Number: 01G06-11
• Device Lot Number: 07887UN20
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 07/22/2021
• 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 C8 PROC MOD, 01G06-11, C804567; CC CREATININE, 03L81-22, 07887UN20; ARC C8 PROC MOD, 01G06-11, C804567