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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PLUS; PROTHROMBIN TIME MONITOR
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ROCHE DIAGNOSTICS COAGUCHEK XS PLUS; PROTHROMBIN TIME MONITOR Back to Search Results
Catalog Number 05021537001
Device Problem Erratic or Intermittent Display (1182)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/19/2018
Event Type  malfunction  
Event Description
The customer had an issue with the display of the coaguchek xs meter that could impact the interpretation of test results.The nurse stated the display was missing pixels in the result field of the display.The nurse performed a display test and confirmed the pixels were damaged.There was no allegation of an adverse event.The suspect product was requested to be returned for investigation.Replacement product was sent.
 
Manufacturer Narrative
The customer¿s meter was returned for investigation and was decontaminated.The error log was displayed an the digits had a weak contrast.Testing was performed without problems and the values were displayed with a weak contrast.No pixels were missing.A cross check of the meter display was performed and it was determined there was an issue with the meter display.
 
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Brand Name
COAGUCHEK XS PLUS
Type of Device
PROTHROMBIN TIME MONITOR
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key8138787
MDR Text Key129898343
Report Number1823260-2018-04685
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 01/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number05021537001
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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