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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME TEST STRIPS

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ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME TEST STRIPS Back to Search Results
Catalog Number 04625374160
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems Thrombosis/Thrombus (4440); Mitral Valve Insufficiency/ Regurgitation (4451)
Event Date 01/18/2022
Event Type  Injury  
Manufacturer Narrative
The reporter's meter was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.2 inr.Qc 2: 5.1 inr.Qc 3: 5.1 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The results alleged by the customer were not observed in the meter¿s patient result memory.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.Occupation: the reporter is the patient's daughter.
 
Event Description
The reporter questioned whether inr results from the coaguchek xs meter with serial number (b)(4) had been accurate as a patient allegedly developed a clot in her st.Jude mitral valve.On (b)(6) 2022, the meter result was 3.2 inr.It was reported that the patient's therapeutic range is 2.5 - 3.5 inr and testing is performed weekly.On (b)(6) 2022, fluoroscopy results reportedly revealed that one of the leaflets of the patient's st.Jude mitral valve was completely stuck, not moving at all and with build-up around it or clotting around that part of the valve.The patient is reportedly being treated by increasing coumadin to try and break up the clot to avoid open-heart surgery.The patient is being closely monitored and the dose is adjusted by the doctor based on the meter results.The reporter alleged there was a meter to laboratory comparison performed and the laboratory result was reportedly 0.3 off from the meter result.The reporter was not able to provide the exact results or the dates and times of the comparison testing.
 
Event Description
The reporter questioned whether inr results from the coaguchek xs meter with serial number (b)(4) had been accurate as a patient allegedly developed a clot in her st.Jude mitral valve.On (b)(6) 2022, the meter result was 3.2 inr.It was reported that the patient's therapeutic range is 2.5 - 3.5 inr and testing is performed weekly.On (b)(6) 2022, fluoroscopy results reportedly revealed that one of the leaflets of the patient's st.Jude mitral valve was completely stuck, not moving at all and with build-up around it or clotting around that part of the valve.The patient is reportedly being treated by increasing coumadin to try and break up the clot to avoid open-heart surgery.The patient is being closely monitored and the dose is adjusted by the doctor based on the meter results.The reporter alleged there was a meter to laboratory comparison performed and the laboratory result was reportedly 0.3 off from the meter result.The reporter was not able to provide the exact results or the dates and times of the comparison testing.
 
Manufacturer Narrative
The reporter's meter was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.2 inr.Qc 2: 5.1 inr.Qc 3: 5.1 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The results alleged by the customer were not observed in the meter¿s patient result memory.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.Occupation: the reporter is the patient's daughter.
 
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Brand Name
COAGUCHEK ® XS SYSTEM
Type of Device
PROTHROMBIN TIME TEST STRIPS
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
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key13545740
MDR Text Key286338872
Report Number1823260-2022-00401
Device Sequence Number1
Product Code GJS
UDI-Device Identifier00365702127104
UDI-Public00365702127104
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
Report Date 02/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date07/31/2022
Device Catalogue Number04625374160
Device Lot Number52333121
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2022
Initial Date Manufacturer Received 01/18/2022
Initial Date FDA Received02/16/2022
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
Treatment
BYSTOLIC; COUMADIN; DIGOXIN; HYDROCHLOROTHIAZIDE; JANTOZEN; JARDIANCE; LOSARTIN POTASSIUM; LOW-DOSE ASPIRIN; METFORMIN HCL; MULTIVITAMINS (VITAFUSION GUMMIES); NIFEDIPINE; PREVASTATIN
Patient Outcome(s) Life Threatening; Other;
Patient Age78 YR
Patient SexFemale
Patient Weight61 KG
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