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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 08/10/2022
Event Type  malfunction  
Event Description
There was an allegation of a display issue with the coaguchek xs meter.The customer saw a "12 on top of a 7" in the upper left-hand corner in the date/time field.The rest of the screen was blank.A display check was performed and confirmed there were no missing segments in the display.There was no allegation of result misinterpretation.
 
Manufacturer Narrative
The meter was requested for return.The investigation is ongoing.
 
Manufacturer Narrative
As no product was received, no further investigation was possible.
 
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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 Key15335079
MDR Text Key305608483
Report Number1823260-2022-02682
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 Health Professional,User Facility
Reporter Occupation Other Health Care Professional
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 Health Professional
Device Model NumberXS PST
Device Catalogue Number03666794001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/10/2022
Initial Date FDA Received09/01/2022
Supplement Dates Manufacturer Received09/27/2022
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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