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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPOCAL INC. EPOC READER

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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.
 
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Brand NameEPOC READER
Type of DeviceEPOC
Manufacturer (Section D)
EPOCAL INC.
2060 walkley road
ottawa, K1G 3 P5
CA K1G 3P5
Manufacturer (Section G)
EPOCAL INC.
2060 walkley road
ottawa, K1G 3 P5
CA K1G 3P5
Manufacturer Contact
felix akinrinola
2 edgewater drive
norwood, MA 02062
6107052212
MDR Report Key9419056
MDR Text Key174172861
Report Number3002637618-2019-00127
Device Sequence Number1
Product Code CGL
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K113726
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/31/2020
1 Device was Involved in the Event
0 Patients were 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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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