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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 04625412003
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/23/2023
Event Type  malfunction  
Manufacturer Narrative
Section e3: occupation is patient/consumer.The customer replaced the batteries.There was no indication of leaking batteries.The meter was requested for investigation.
 
Event Description
There was an allegation of a display issue with a coaguchek xs meter.The date of event is an approximation.The reporter stated the issue occurred in "the last weeks." the customer alleged the display was becoming weaker and weaker and that there were "some" segments missing from the results field.
 
Manufacturer Narrative
Sections d9 and h3 were updated.The meter was received for investigation.The device could not be turned on.It was found that the battery contacts and the printed circuit board (pcb) were contaminated by penetrated liquid which penetrated/corroded the solder contacts.This affects the battery contacts and the conductive rubber contacts on the circuit board and caused the issue observed by the customer.The investigation determined the event was due to contamination of the contacts due to improper customer handling or maintenance.
 
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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
sandhofer strasse 116
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
amy nelson
9115 hague road
indianapolis, IN 46250
MDR Report Key17565182
MDR Text Key321381426
Report Number1823260-2023-02677
Device Sequence Number1
Product Code GJS
Combination Product (y/n)Y
Reporter Country CodeGM
PMA/PMN Number
K062925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/28/2023
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 Catalogue Number04625412003
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 07/24/2023
Initial Date FDA Received08/17/2023
Supplement Dates Manufacturer Received09/19/2023
Supplement Dates FDA Received09/28/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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