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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
Catalog Number 03666794001
Device Problem Erratic or Intermittent Display (1182)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/17/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer complained of missing segments in the results field of the coaguchek xs meter that may impact the interpretation of results.The customer stated when he inserted the test strip the meter beeped but only a "spot' was flashing on the display.He pressed the power button and had one spot flashing.The customer performed a display check and could not see any icons or digits.He could only see 5 dashes across the middle of the display.There was no allegation of an adverse event.The suspect product was requested to be returned for investigation.
 
Manufacturer Narrative
The meter was returned for investigation.Upon investigation of the returned meter, a defect in the circuit board or an electronic component of the circuit board was found.
 
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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 Key7572639
MDR Text Key110175196
Report Number1823260-2018-01753
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 consumer
Type of Report Initial,Followup
Report Date 07/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number03666794001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2018
Date Manufacturer Received05/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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