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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 COAGUCHEK XS PST
Device Problems Image Display Error/Artifact (1304); Non Reproducible Results (4029)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2022
Event Type  malfunction  
Event Description
We received an allegation of a display issue on a coaguchek xs meter.The patient alleged that she gets either a 1.3 inr or 3.1 inr each time she tests.Upon review of the meter memory, there was only one result within the last 5 that matched that allegation (1.3 inr on (b)(6) 2022).The patient alleged that after she gets the results that are there in the meter memory, she powers the meter off using the "i" button and back on, and she will see a different result in the results field.The patient turned the meter off using the "i" button and then back on.The patient alleged a result of 2.1 display with no unit of measure (no inr, sec, or %q).A display check was performed.The patient clearly read the three 8's in the results field.There were no missing or abnormal segments.Once the "i" button was released after the display check, the patient saw 2.1 on the screen again where the three 8s had been.
 
Manufacturer Narrative
Initial reporter occupation is patient/consumer.The patient's meter was requested for investigation.
 
Manufacturer Narrative
The customer did not return any materials for investigation.Without these materials 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 Key16072853
MDR Text Key308290092
Report Number1823260-2022-04237
Device Sequence Number1
Product Code GJS
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 02/22/2023
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 Model NumberCOAGUCHEK XS PST
Device Catalogue Number03666794001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/08/2022
Initial Date FDA Received12/29/2022
Supplement Dates Manufacturer Received01/26/2023
Supplement Dates FDA Received02/22/2023
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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