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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 Circuit Failure (1089)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/10/2020
Event Type  malfunction  
Manufacturer Narrative
The customer¿s device was requested for investigation.The investigation is ongoing.
 
Event Description
The initial reporter stated they had an issue with the display for the coaguchek xs meter, which could affect the interpretation of the customer¿s results.The device's display has missing segments.The initial reporter stated she could only see the full battery symbol on the lower left side of the display when she had attempted to perform a full screen display check.No actual misinterpretation of a result occurred.
 
Manufacturer Narrative
The customer's meter was received for investigation.The m button did not respond, not all displays could be checked.The display shows no error during investigation.The meter¿s circuit board was tested for damage or contamination and it was found the printed circuit board (pcb) was contaminated.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 Key10523770
MDR Text Key248853335
Report Number1823260-2020-02191
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 health professional
Type of Report Initial,Followup
Report Date 10/01/2020
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 Model NumberXS PST
Device Catalogue Number03666794001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2020
Initial Date Manufacturer Received 08/10/2020
Initial Date FDA Received09/11/2020
Supplement Dates Manufacturer Received08/10/2020
Supplement Dates FDA Received10/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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