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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 08/23/2022
Event Type  malfunction  
Manufacturer Narrative
Occupation is patient/consumer.The customer noted that all 4 battery contacts in the battery compartment were corroded.He stated the meter had not been exposed to liquid.The meter was requested for investigation.
 
Event Description
We received an allegation of a display issue with a coaguchek xs meter.A display check was performed and the customer alleged that "everything is scrambled." the "888" in the results field looked like "666." when the meter memory was reviewed, there was a result of either 2.1 or 2.2; the customer stated he could only see the first 2.The customer stated the results were very clear the last time he tested.He stated there was no chance of misinterpreting results; he hasn¿t tested since he noticed the missing segments.
 
Manufacturer Narrative
Sections d9 and h3 were updated.The meter was received for investigation.The meter could not be turned on.A visual examination was performed.The battery contacts in the battery compartment and the circuit board were contaminated by liquid (leaked battery) which penetrated and corroded the solder contacts.This affects the area of the conductive rubber contacts on the circuit board and caused the issue the customer complained about.The investigation determined the cause of the event was contamination of the contacts due to improper handling or maintenance by the customer.
 
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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 Key15405017
MDR Text Key305888527
Report Number1823260-2022-02802
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 10/13/2022
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 08/23/2022
Initial Date FDA Received09/12/2022
Supplement Dates Manufacturer Received09/19/2022
Supplement Dates FDA Received10/13/2022
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 SexMale
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