MAUDE Adverse Event Report: EPOCAL INC. EPOC READER & POWER SUPPLY

Model Number HR-1002-00-00

Device Problem Non Reproducible Results (4029)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results.The customer did not provide the card lot number for investigation.It has been requested.If the card lot is provided, this issue will be investigated by looking at in-house data, finished goods testing, lifetime testing, retain testing and a search to see if there are any other complaints on this same card lot.The cause of this event is unknown.

Event Description

The customer reported a discrepant high hematocrit result when tested for a total of three times on the epoc reader and compared the result to a non-siemens hematology analyzer.There was no report of injury due to this event.

Manufacturer Narrative

After multiple requests for information by the complaint preparer, the customer was unable to provide the required information to perform an investigation.Dcu showed due diligence in attempting to obtain information 5 different times.The complaint preparer left additional messages without success.Without an investigation, the root cause cannot be determined and therefore the complaint cannot be confirmed.Siemens recommends that the customer review their sample collection protocol and practice proper sample handling, as this may have a direct impact on the hematocrit.Additionally, the type of anticoagulant used as well as testing delays can also impact test results if not properly considered.

• Brand Name: EPOC READER & POWER SUPPLY
• Type of Device: EPOC
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• MDR Report Key: 11688578
• MDR Text Key: 252235887
• Report Number: 3002637618-2021-00028
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708016685
• UDI-Public: 00809708016685
• Combination Product (y/n): N
• PMA/PMN Number: K113726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• 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
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1