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 Problem Hematuria (2558)

Event Date 01/20/2022

Event Type  Injury  

Event Description

It was alleged that a patient had a bleeding event on approximately (b)(6) 2022, a second bleeding event in late (b)(6) 2022, and a third bleeding event that began on or around (b)(6)2022.The specific date of the event is not known.The patient uses coaguchek xs meter serial number (b)(4).The patient's therapeutic range is reported as 2.0-2.5 inr.The patient's wife reported that the patient started dialysis after a bleeding event in the hospital in (b)(6) 2022.It was reported during the call that the meter's patient result memory had the following values prior to the bleeding event in (b)(6) 2022: 3.2 inr at 12:00 p.M.On (b)(6) 2021.1.7 inr at 1:40 p.M.On (b)(6) 2022.1.8 inr at 11:40 a.M.On (b)(6) 2022.3.1 inr at 10:30 a.M.On (b)(6) 2022.2.1 inr at 12:00 p.M.On (b)(6) 2022.The patient's wife reported that she thinks the patient went to the hospital on (b)(6) 2022.It was reported the patient had blood in his stoma/urine bag and had a urinary tract infection at the time.The patient's inr results were not known.The treatment provided to the patient is unknown.It was reported the patient did not require surgery to stop the bleeding.It was reported that the patient was in the hospital and rehabilitation facilities for a total of 4 months.The patient's wife could not recall the patient's anticoagulation dosage amounts or if there were any changes in dosage.The patient's wife reported that the patient also went to the hospital in late (b)(6) of 2022 due to a lot of bleeding from his stoma.The exact date of this occurrence is not known.According to the meter's patient result memory, the following values were reported around the time of the bleeding event in late (b)(6) 2022: 1.7 inr at 8:32 a.M.On (b)(6) 2022.1.7 inr at 4:39 p.M.On (b)(6) 2022.1.8 inr at 12:22 p.M.On (b)(6) 2022.1.3 inr at 12:38 p.M.On (b)(6) 2022.1.1 inr at 8:39 a.M.On (b)(6) 2022.The patient's wife reported that the patient's normal anticoagulation medication dose was 5 mg.Daily.It was reported that when the patient obtained low results in (b)(6) 2022, the patient's dose was increased to 7.5 mg.For 2 days a week and 5 mg.For the remaining days.It was reported that prior to the patient's hospital admission for the event in late (b)(6) 2022, the patient had a dialysis session the day before.The patient's wife reported that she did not recall the patient's inr levels upon admission of the patient in late (b)(6) 2022.The patient's wife reported she did not believe the patient received treatment for inr levels during that time.It was reported that during the bleeding event in late (b)(6) 2022, the patient had a computed tomography (ct) scan and a magnetic resonance imaging (mri) scan that showed the patient's bleeding originated from the kidney.It was reported that the patient's doctors did not know what caused the bleeding.It was reported that the patient was diagnosed with a urinary tract infection and was given massive amounts of antibiotics intravenously.It was reported that the patient did not require surgery to stop the bleeding and the patient did not receive a blood transfusion.It was reported that the patient received treatment with procrit via hemodialysis.It was reported that the patient was in the hospital for approximately 1 week and the patient was not in the intensive care unit.When calling for assistance on (b)(6) 2022, the patient's wife reported that the patient recently got out of the hospital and has started bleeding again from the stoma/urine bag.On (b)(6) 2022, the patient's wife reported that the patient is still bleeding from stoma/urostomy bag.It was reported that the patient has a urinary tract infection and has been prescribed ceftin.The patient is reported to be at home currently and warfarin was stopped.The following information was requested, but not provided: the patient's hemoglobin and hematocrit levels during the time of the bleeding events.Information on whether the reported meter values were measured before or after dialysis.Laboratory inr results before and after dialysis of the patient.Type of antibiotics given to the patient.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

The customer's meter was requested for investigation.The test strips used by the customer were discarded and are not available for return.The reporter's meter was provided for investigation where it was tested using retention strips and controls.Testing results (qc range = 4.1 ¿ 6.8 inr): qc 1: 5.3 inr, qc 2: 5.2 inr, qc 3: 5.3 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.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.According to the returned meter's patient result memory, the following measurement dates/times were observed to be different than what was reported on the call: the value reported on the call as "3.2 inr at 12:00 p.M.On (b)(6) 2021" was actually measured at 12:41 on (b)(6) 2021.The value reported on the call as "1.7 inr at 1:40 p.M.On (b)(6) 2022" was actually measured at 14:23 on (b)(6) 2022.The value reported on the call as "1.8 inr at 11:40 a.M.On (b)(6) 2022" was actually measured at 12:21 on (b)(6) 2022.The value reported on the call as "3.1 inr at 10:30 a.M.On (b)(6) 2022" was actually measured at 10:41 on (b)(6) 2022.The value reported on the call as "2.1 inr at 12:00 p.M.On (b)(6) 2022" was actually measured at 12:47 on (b)(6) 2022.Initial reporter occupation - the occupation is patient/consumer.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15476041
• MDR Text Key: 300595834
• Report Number: 1823260-2022-02916
• 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: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2022
• 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: WARFARIN.
• Patient Outcome(s): Hospitalization
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 77 KG