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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 03666794001
Device Problem Circuit Failure (1089)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/25/2020
Event Type  malfunction  
Manufacturer Narrative
Occupation is lay user/patient.The customer¿s device was requested for investigation, but has not been returned.The investigation is ongoing.
 
Event Description
The initial reporter complained of a coaguchek xs meter display issue, which could cause misinterpretation of results.The customer stated the meter lost power, and the right side of the meter's display appeared darkened.The customer reported the display "appears to show a burned appearance." the customer confirmed there was no evacuation, smoking, burning, or melting, the customer replaced the meter's batteries last week due to meter power loss.The customer noticed one of the batteries had leaked inside the meter when the batteries were replaced.The customer cleaned inside the battery compartment prior to placing the new batteries in the meter.The customer was able to turn on the meter, but the meter turned off after pressing the "m" button during testing.The customer was unable to perform a meter display check or confirm if the results field showed missing segments.The customer removed the new batteries and checked the battery compartment for corrosion.No corrosion was observed.The customer confirmed the meter was not dropped or damaged.No misinterpretation of results occurred.
 
Manufacturer Narrative
The display showed no issues during the investigation.The meter¿s circuit board was tested for damage or contamination and it was found that the battery contacts and printed circuit board are contaminated by liquid (leaked battery) which has penetrated / corroded solder contacts.The observed contamination can lead to the reported display issue.The root cause is determined to be contamination of the contacts due to improper handling or maintenance by the customer.Medwatch fields d9 and h3 were 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
MDR Report Key10703729
MDR Text Key213685211
Report Number1823260-2020-02589
Device Sequence Number1
Product Code GJS
Combination Product (y/n)N
PMA/PMN Number
K062925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 11/11/2020
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 Number03666794001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2020
Initial Date Manufacturer Received 09/25/2020
Initial Date FDA Received10/20/2020
Supplement Dates Manufacturer Received09/25/2020
Supplement Dates FDA Received11/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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