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

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.

• 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 Key: 13545740
• MDR Text Key: 286338872
• Report Number: 1823260-2022-00401
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• 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 Date: 07/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 52333121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/16/2022
• 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 Number: 1
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Weight: 61 KG