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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 Known Impact Or Consequence To Patient (2692)
Event Date 12/09/2019
Event Type  malfunction  
Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results which met the clinical picture.The customer is being sent a new epoc reader.Siemens has requested more information to properly assess this complaint but to date, none has been received.The cause of this event is unknown.
 
Event Description
The customer reported discrepant po2 results between the initial and repeat results on the epoc reader.There was no report of injury due to this event.
 
Manufacturer Narrative
Siemens has reached out to the customer multiple times requesting more information to properly assess this complaint.No further information has been received from the customer including the lot number of the reagent in use.Without more information or the lot of reagent in use at the time of the discrepancy, further investigation is not possible.The customer was sent a new epoc reader.Root cause of this event is unknown.
 
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Brand Name
EPOC READER
Type of Device
EPOC READER
Manufacturer (Section D)
EPOCAL INC.
2060 walkley road
ottawa, K1G 3 P5
CA  K1G 3P5
MDR Report Key9476606
MDR Text Key174175674
Report Number3002637618-2019-00133
Device Sequence Number1
Product Code CGL
UDI-Device Identifier00809708016685
UDI-Public00809708016685
Combination Product (y/n)N
PMA/PMN Number
K113726
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Remedial Action Replace
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 Received12/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number10736398
Was Device Available for Evaluation? No
Date Manufacturer Received01/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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