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

Catalog Number 03666794001

Device Problem Circuit Failure (1089)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/18/2022

Event Type  Injury  

Event Description

We received an allegation of a power issue with coaguchek xs meter serial number (b)(4).The patient was reportedly unable to test on the meter due to power loss of the meter for approximately 2 weeks leading up to a bleeding event requiring hospitalization.No information was provided about whether the patient sought alternative inr testing during the time period preceding the bleeding event described below.On (b)(6) 2022 the patient reportedly returned from dialysis and started bleeding from fistula site.The patient was reportedly sent to the er due to uncontrolled bleeding requiring 3 units of blood and plasma.The patient's hct was requested but was not provided.The patient's inr in the er was reportedly 16 inr, though no medical records have been provided.The physician allegedly asked if the patient had been testing his inr; the patient reportedly advised he had not been able to test on the meter due to the power loss.The patient was reportedly hospitalized for 4 days.On (b)(6) 2022, the physician was able to get the meter to work.The patient was able to test on the meter with a result of 4.7 inr.On (b)(6) 2022 the patient reportedly had a lab result of 1.86 inr.The physician adjusted the patient's warfarin dose.The patient is reportedly now taking 5 mg of warfarin for 1 day and the other 6 days he reportedly takes 2.5 mg.The patient's therapeutic range is allegedly 2.5 - 3.5 inr.The patient¿s inr testing interval is every two weeks.

Manufacturer Narrative

Occupation is patient's caregiver.The patient's caregiver replaced the batteries but the meter did not turn on.After following troubleshooting steps on the call, the meter did not resume power.The meter was requested for investigation and replacement product will be sent.

Manufacturer Narrative

It was clarified that the patient's caregiver replaced the batteries a "couple of days" prior to the event on (b)(6) 2022.The meter has not been received for investigation.Since the product was not returned for investigation, the cause of the event could not be determined.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• 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: 14514840
• MDR Text Key: 292727650
• Report Number: 1823260-2022-01491
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• 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,Followup
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2022
• 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: CARVEDILOL; EZETIM-SIMVA; FUROSEMIDE; METHIMAZOLE; MULTIVITAMINS; PERCOCET; PREDNISONE; SERTRALINE; VITAMIN B12; VITAMIN C; VITAMIN D3; WARFARIN
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male