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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 Problems Image Display Error/Artifact (1304); Device Difficult to Setup or Prepare (1487)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter occupation: occupation is patient/consumer (customer's son reported the issue).The meter was requested for investigation.The investigation is ongoing.
 
Event Description
The customer complained of a display issue with coaguchek xs meter serial number (b)(4).Customer states the meter displays a result of 0 with no result units.The display check confirmed three eights were displayed in the results field as expected.No misinterpretation of results was reported.
 
Manufacturer Narrative
The customer's meter was returned for investigation.It was observed that the meter powered on with fresh retention batteries.A full display check was performed and revealed no missing or faded segments.No display issues were observed.The customer's returned meter was tested using retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 4.9 inr qc 2: 4.9 inr qc 3: 5.0 inr the obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The customer's allegation could not be reproduced.The returned meter performed according to specifications.Medwatch fields d9.And h3.Have been updated.
 
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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 Key15951188
MDR Text Key305555659
Report Number1823260-2022-03952
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 12/29/2022
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 11/16/2022
Initial Date FDA Received12/09/2022
Supplement Dates Manufacturer Received12/14/2022
Supplement Dates FDA Received12/29/2022
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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