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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 07/23/2020
Event Type  malfunction  
Manufacturer Narrative
The customer¿s device was requested for investigation.Occupation is lay user/patient.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 faint segments that are difficult to read.No actual misinterpretation of a result occurred.
 
Manufacturer Narrative
The customer's meter was received for 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 d10 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 Key10410478
MDR Text Key203126468
Report Number1823260-2020-02006
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 09/08/2020
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 Manufacturer08/17/2020
Initial Date Manufacturer Received 07/23/2020
Initial Date FDA Received08/14/2020
Supplement Dates Manufacturer Received07/23/2020
Supplement Dates FDA Received09/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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