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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 PST
Device Problem Circuit Failure (1089)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/13/2020
Event Type  malfunction  
Manufacturer Narrative
Occupation is lay user/patient.The meter was requested for investigation.
 
Event Description
The initial reporter complained of a display issue with a coaguchek xs meter.The reporter stated when a test strip was inserted into the meter the code number of "419" displayed as "417." the code number is made up from the results field segments.The issue with the code number could impact the interpretation of results.The code key was removed and checked; the code number on the code key was "419." a display check was performed and all segments in the results field were complete.The reporter inserted another test strip into the meter and the code number displayed as "419" correctly.
 
Manufacturer Narrative
The customer's meter was received for investigation.The display showed no issues during the investigation the device has been disassembled and its electronic compartment has been visually inspected.No contamination or other abnormalities are visible.No root cause or any other evidence for missing segments were found.The mentioned problem could not be reproduced.Medwatch fields d10 and h3 were updated.
 
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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 Key10372809
MDR Text Key202051703
Report Number1823260-2020-01903
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 08/28/2020
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 Model NumberXS PST
Device Catalogue Number03666794001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2020
Initial Date Manufacturer Received 07/13/2020
Initial Date FDA Received08/06/2020
Supplement Dates Manufacturer Received07/13/2020
Supplement Dates FDA Received08/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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