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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 Problems Image Display Error/Artifact (1304); Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2022
Event Type  malfunction  
Event Description
We received an allegation of a display issue with a coaguchek xs meter.The customer was also having meter power issues.The meter powered on but the customer alleged the display was "half faded." the batteries were corroded and replaced.After replacing the batteries, the display still appeared half faded.Upon completion of a display check, the "888" in the results field looked like "666." the meter memory was accessed and the result was 1.9 inr.The customer stated half of the "1" and half of the "9" were showing on the display screen.
 
Manufacturer Narrative
Initial reporter occupation is patient/consumer.The meter was requested for investigation.
 
Manufacturer Narrative
The customer did not return any material for investigation.Without the material 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
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 Key15450969
MDR Text Key306213604
Report Number1823260-2022-02874
Device Sequence Number1
Product Code GJS
UDI-Device Identifier04015630945689
UDI-Public04015630945689
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 10/20/2022
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 Catalogue Number03666794001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/25/2022
Initial Date FDA Received09/19/2022
Supplement Dates Manufacturer Received10/04/2022
Supplement Dates FDA Received10/20/2022
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
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