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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPOCAL INC. EPOC HOST 2 MOTOROLA

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EPOCAL INC. EPOC HOST 2 MOTOROLA Back to Search Results
Catalog Number 10736387
Device Problem Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 02/16/2020
Event Type  malfunction  
Manufacturer Narrative
Siemens has requested additional information several times to properly assess this event but to date it has not been provided. The data files have been received for investigation. The customer stated the qc was performing as expected at the time of the event. Twenty cards of lot 01-19291-20 were tested in the epocal r&d lab. All twenty cards reported na+ and k+ results within expected correlation to abl. No sample delivery errors were observed. Siemens investigators also reviewed the lab results. Both na+ and k+ are acceptable on the in-house tests and well centered within the post drift and delta drift limits. Approximately 11,950 cards were released from lot 01-19291-20. There have been no other complaints. The cause of this issue is unknown.
 
Event Description
The customer reported that the epoc host/reader did not provide sample results for approximately five days on a critically ill patient. The patient is diseased. The system appears to be working as intended by giving error messages to indicate no results could be reported.
 
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Brand NameEPOC HOST 2 MOTOROLA
Type of DeviceEPOC HOST
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 
7052212
MDR Report Key9826159
MDR Text Key183179174
Report Number3002637618-2020-00010
Device Sequence Number1
Product Code CGL
Combination Product (y/n)N
Reporter Country CodeCO
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 04/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number10736387
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 Received04/16/2020
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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