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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 09/03/2020
Event Type  malfunction  
Manufacturer Narrative
The customer¿s products have been requested for return.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.Occupation was lay user/patient.
 
Event Description
The initial reporter had an issue with the display of the coaguchek xs meter that could result in a misinterpretation of results.The initial reporter stated the segments in the results field of the display are partially fading.There was no allegation of any actual misinterpreted results.
 
Manufacturer Narrative
The customer's meter was received for investigation.The meter¿s circuit board was tested for damage or contamination and no contamination was found on the printed circuit board (pcb).The display shows no error during investigation (no missing or fainted segments).The circuit board shows no contamination that could temporarily lead to the complained error.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 Key10585611
MDR Text Key208541554
Report Number1823260-2020-02356
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 11/04/2020
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 Manufacturer10/09/2020
Initial Date Manufacturer Received 09/03/2020
Initial Date FDA Received09/25/2020
Supplement Dates Manufacturer Received09/03/2020
Supplement Dates FDA Received11/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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