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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 04837738001
Device Problems Display Difficult to Read (1181); Image Display Error/Artifact (1304)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2023
Event Type  malfunction  
Manufacturer Narrative
The meter was requested for investigation.
 
Event Description
We received an allegation of a display issue with a coaguchek meter.The reporter stated that the meter was broken.Upon changing the batteries, the meter powered on but the screen did not fully show the display.The reporter stated that the meter had missing segments on the display which impacts patient result interpretation.A display check was performed.The reporter stated that "000" was visible but the eights were not seen; the segments were missing.Upon pressing "m" for the meter memory, there was only "32.00" on the upper right of the screen.
 
Manufacturer Narrative
Medwatch fields d9 and h3 were updated, the meter was received for investigation.The investigation determined that the device could not be turned on.The device data and fault memory could not be read out.The circuit board was tested for damage or contamination.The battery contacts and printed circuit board (pcb) were contaminated by penetrated liquid (leaked battery) which corroded the solder contacts.This affected the battery contacts and the conductive rubber contacts on the circuit board and caused an interruption.The investigation determined that the event was caused by the contamination of the contacts due to improper handling or maintenance.Product labeling states: "if you store the meter for a period of time, remove the batteries." "please follow the procedures below to clean and disinfect the meter.Failure to follow these procedures may cause malfunction of the meter.Do not use sprays of any sort.Ensure that swab or cloth is only damp, not wet." "wipe away residual moisture and fluids after cleaning the housing.".
 
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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 Key17560404
MDR Text Key321692236
Report Number1823260-2023-02662
Device Sequence Number1
Product Code GJS
UDI-Device Identifier00365702125100
UDI-Public00365702125100
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 10/12/2023
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 Number04837738001
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/20/2023
Initial Date FDA Received08/16/2023
Supplement Dates Manufacturer Received09/21/2023
Supplement Dates FDA Received10/12/2023
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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