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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PLUS; PROTHROMBIN TIME MONITOR

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ROCHE DIAGNOSTICS COAGUCHEK XS PLUS; PROTHROMBIN TIME MONITOR Back to Search Results
Catalog Number 05021537001
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2022
Event Type  malfunction  
Event Description
We received an allegation of a display issue with 3 coaguchek xs meters.This mdr is for meter #2.The meter has black lines on the screen.The reporter described the screen as "similar to an old tv".It was verified that the lines would interfere with the interpretation of results.No misinterpretation of results was reported.Refer to mdr with patient identifier (b)(6) for the investigation of meter #1 and mdr with patient identifier (b)(6) for the investigation of meter #3.
 
Manufacturer Narrative
The meter was requested for investigation.A replacement meter was sent to the customer.
 
Manufacturer Narrative
The product was not submitted for investigation.If the product is returned in the future, a follow-up report will be submitted.
 
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Brand Name
COAGUCHEK XS PLUS
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 Key15394352
MDR Text Key305725026
Report Number1823260-2022-02776
Device Sequence Number1
Product Code GJS
UDI-Device Identifier00365702164109
UDI-Public00365702164109
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 10/24/2022
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 Catalogue Number05021537001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/17/2022
Initial Date FDA Received09/09/2022
Supplement Dates Manufacturer Received09/28/2022
Supplement Dates FDA Received10/24/2022
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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