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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME MONITOR
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ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME MONITOR Back to Search Results
Model Number XS PLUS
Device Problem Erratic or Intermittent Display (1182)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/19/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer complained of a display issue with coaguchek xs plus meter with an unspecified serial number.The customer alleged that the display on the meter fades out and they have trouble seeing the patient results.The customer alleges this could have the potential for staff to not see the result for a patient clearly leading to a misinterpretation of a result.The customer states when the display on the meter fades out, they start the test over and obtain a successful result; the result is displayed and interpreted correctly.The customer also stated the meter sometime turns off during testing.The customer will start the test over and the next attempt is successful; the meter stays powered on.No adverse event occurred.The device was requested for investigation.
 
Manufacturer Narrative
The customer¿s meter was returned for investigation and no abnormalities were detected.The returned meter was tested with retention controls and strips.
 
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Brand Name
COAGUCHEK ® XS SYSTEM
Type of Device
PROTHROMBIN TIME MONITOR
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key7331930
MDR Text Key102215871
Report Number1823260-2018-00775
Device Sequence Number1
Product Code GJS
Combination Product (y/n)N
PMA/PMN Number
K062925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 05/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberXS PLUS
Device Catalogue Number04562780001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2018
Date Manufacturer Received02/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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