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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 Image Display Error/Artifact (1304)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2023
Event Type  malfunction  
Event Description
There was an allegation of a display issue with a coaguchek xs meter.The customer stated that part of the display screen was not lighting up; it appeared to be fading.Upon completion of a display check, only part of the display segments were visible.The customer stated the bottom half of the display screen was faded and the bottom half of the results field was faded and not bright like the upper half of the screen.
 
Manufacturer Narrative
Section e3: occupation is patient/consumer.The battery compartment did not appear corroded.The meter was requested for investigation.
 
Manufacturer Narrative
Sections d9 and h3 were updated.The meter was received for investigation.The circuit board was contaminated by penetrated liquid.This affects the conductive rubber contacts on the circuit board.The investigation determined the event was due to contamination of the contacts due to improper handling or maintenance by the customer.
 
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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
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhofer strasse 116
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
amy nelson
9115 hague road
indianapolis, IN 46250
MDR Report Key18217349
MDR Text Key329132114
Report Number1823260-2023-03775
Device Sequence Number1
Product Code GJS
UDI-Device Identifier04015630945689
UDI-Public04015630945689
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K062925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/27/2023
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? Device Returned to Manufacturer
Initial Date Manufacturer Received 11/08/2023
Initial Date FDA Received11/28/2023
Supplement Dates Manufacturer Received12/22/2023
Supplement Dates FDA Received12/27/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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