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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 Circuit Failure (1089)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/16/2020
Event Type  malfunction  
Manufacturer Narrative
The customer¿s device was requested for investigation, but has not been returned.The investigation is ongoing.
 
Event Description
The initial reporter complained of a display issue with a cc-xs meter, which could cause misinterpretation of results.The reporter stated display segments are missing from the three 8¿s.Also, the meter does not show the time, date, strip, symbol, and previous inr results.The customer has not attempted to perform a test and no misinterpretation of results were reported.
 
Manufacturer Narrative
The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.
 
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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 Key10384062
MDR Text Key202406789
Report Number1823260-2020-01928
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 09/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? No
Initial Date Manufacturer Received 07/16/2020
Initial Date FDA Received08/10/2020
Supplement Dates Manufacturer Received07/16/2020
Supplement Dates FDA Received09/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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