MAUDE Adverse Event Report: EPOCAL INC. EPOC BLOOD ANALYSIS SYSTEM; EPOC READER

Catalog Number	10736404
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a discrepant low creatinine result compared to retesting of the same? sample on their laboratory instrument.Customer stated that the level 1 qc failed low for creatinine on (b)(6).There is no report of injury due to this event.
Additional Manufacturer Narrative
Siemens requested instrument log files for further investigation.The customer stated that level 1 qc for creatinine failed low the day prior to the event.Siemens does not recommend running patient samples if quality controls are not passing.The cause of this event is unknown.
Additional Manufacturer Narrative
The information provided by the customer was reviewed.Without the requested instrument file, a full investigation was unable to proceed.However, a review of the lot performance of the card lot in question at the time of the event was performed.The in-house performance of creatinine for the card lot in question did not identify any product deficiencies.Review of testing performed at release, throughout product lifetime, and additional testing did not show any anomalies that aligns with the observation in the customer allegation.No product problem identified.The cause of this event is unknown.

• Brand Name: EPOC BLOOD ANALYSIS SYSTEM
• Common Device Name: EPOC READER
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• Manufacturer (Section G): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 18181492
• Report Number: 3002637618-2023-00099
• Device Sequence Number: 20770076
• Product Code: CHL
• UDI-Device Identifier: 00809708116712
• UDI-Public: 00809708116712
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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: 10736404
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown