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

Catalog Number 10736404

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2023

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 328631159
• Report Number: 3002637618-2023-00099
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 00809708116712
• UDI-Public: 00809708116712
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K200107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 10736404
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 11/15/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1