MAUDE Adverse Event Report: EPOCAL INC. EPOC READER

Model Number HR-1002-00-00

Device Problem High Test Results (2457)

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

Event Date 12/29/2021

Event Type  malfunction  

Manufacturer Narrative

The customer compared results that were taken three weeks apart.No comparative testing was performed at the time the disrepant result was received.The customer stated that they expected a result closer to that received previously due to the patient's clinical picture.The customer also stated that expired capillary tube were used to obtain the sample.Siemens reviewed in-house performance data of the lot in question and found no product deficiencies.Additionally, it was noted the customer was using earlobe capillary samples.The process of capillary collection may change po2 levels significantly and is susceptible to factors such as air contamination.According to clsi c46-a blood gas and ph analysis and related measurements; approved guideline, arterial blood samples are preferred for blood gas analysis.

Event Description

The customer reported a discrepant high ph result from their epoc instrument compared to the results obtained three weeks prior from a non-siemens lab instrument.There is no report of injury due to this event.

• Brand Name: EPOC READER
• Type of Device: EPOC
• 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 ; 6107052212
• MDR Report Key: 13307530
• MDR Text Key: 284876865
• Report Number: 3002637618-2022-00007
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708016685
• UDI-Public: 00809708016685
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HR-1002-00-00
• Device Catalogue Number: 10736398
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1