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EPOCAL INC. EPOC READER Back to Search Results
Catalog Number 10736398
Device Problem Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/07/2019
Event Type  malfunction  
Manufacturer Narrative
The hct and hgb performance for card lot 00-19193-10 will be investigated. The customer stated they are operational. The cause of this event is unknown.
Event Description
The customer reported discrepant hematocrit and hemoglobin results on the epoc reader when compared to a repeat on the same instrument and a non-siemens lab analyzer. There was no report of injury due to this event.
Manufacturer Narrative
The raw waveform data (provided by customer) was analyzed. Based on the limited information available, it is possible a blood clot or sample injection issue occurred on the test in question, indicating more of a sample handling/user injection related issue than a product deficiency. The cause of the discrepancy could not be determined. A review of the in-house performance of the card lot in use, lot 00-19193-10, did not identify any product deficiencies. In addition, a search of the complaint handling system (gsms) for the card lot did not return any other related complaints. Therefore, we conclude that there is no indication of a failure of the system to perform as intended. The customer is operational.
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Type of DeviceEPOC
Manufacturer (Section D)
2060 walkley road
ottawa, K1G 3 P5
CA K1G 3P5
MDR Report Key9419056
Report Number3002637618-2019-00127
Device Sequence Number1
Product Code CGL
UDI-Device Identifier00809708016685
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number10736398
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Age86 YR