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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 Image Display Error/Artifact (1304)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter occupation: occupation is patient/consumer.There was no moisture or debris in the battery compartment.The heater plate was clean and dry.The meter was requested for investigation.
 
Event Description
We received an allegation of a display issue with a coaguchek xs meter.On (b)(6) 2022 the result in the meter memory looked like 8.2 inr.The result was actually 3.2 inr.The patient reported a result of 8.2 inr; the patient held her medication for one night.The patient was not harmed by holding her medication.On (b)(6) 2022 the result in the meter memory looked like 11.9 inr.The result was actually 1.9 inr.The patient reported a result of 11.9 inr; no medication changes were made.The patient went to the doctor where the result from an unknown method was also 1.9 inr.The patient stated her vision is poor and she can¿t read the results correctly.She stated when she tilts the meter she is able to see the correct results.A display check was performed and the display was complete with no missing segments.
 
Manufacturer Narrative
The meter was received for investigation.The meter display was examined and the segments showed a weak contrast.The non-active segments may also appear faint.The investigation found contamination of the conductive rubber contacts which leads to the issue observed.The cause of the event was the contamination of the contacts which is due to improper customer handling or maintenance.
 
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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
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
amy nelson
9115 hague road
na
indianapolis, IN 46250
3174767531
MDR Report Key15456939
MDR Text Key306417325
Report Number1823260-2022-02885
Device Sequence Number1
Product Code GJS
UDI-Device Identifier00365702125100
UDI-Public00365702125100
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/07/2022
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 Number04837738001
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/25/2022
Initial Date FDA Received09/20/2022
Supplement Dates Manufacturer Received10/28/2022
Supplement Dates FDA Received11/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient SexFemale
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