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 Hemorrhage/Bleeding (1888)

Event Date 10/08/2021

Event Type  Injury  

Manufacturer Narrative

The meter and strips were requested for investigation.Replacement product was sent.The patient's meter was provided for investigation where it was tested using retention strips and retention controls.The patient did not have test strips to return for investigation.Testing results (qc range = 2.5 - 3.7 inr): qc 1: 3.1 inr; qc 2: 3.1 inr; qc 3: 3.1 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.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.The investigation did not identify a product problem.The cause of the event could not be determined.Occupation is patient/consumer (patient's husband).

Event Description

There was an allegation of questionable inr results with a coaguchek vantus meter serial number (b)(4) that led to a bleeding event requiring surgical intervention and hospitalization.The patient's therapeutic range was 2.6-3.1 inr.The testing frequency was reported to be one to two times per week.On (b)(6) 2021, at 21:03, the patient's meter result, verified in the returned meter memory, was 1.3 inr.The patient's warfarin dosage was reportedly changed based on this reading.It was reported that changes may have been made to the patient's other medication.The specific changes made could not be provided by the reporter and there is reportedly no record of the changes made.The reporter estimated that on or around (b)(6) 2021, the patient reportedly went to the hospital due to difficulty in breathing and not feeling well.Upon arrival at the hospital, the patient's laboratory inr result by an unknown method was reportedly 10.0 inr, and the patient's hemoglobin result was reportedly "6 or 7" and the hematocrit result was unknown.A computed tomography (ct) scan was performed and reportedly a stomach hemorrhage was found.The patient reportedly had surgery where an artery in the stomach was repaired but the cause of the stomach hemorrhage was not determined.While at the hospital, the patient was provided 3 units of blood during the night of (b)(6) 2021, 1 unit of blood during the day on (b)(6) 2021, and 1 unit of blood during the day on (b)(6) 2021.Also, it was reported the patient was provided insulin due to the patient's sugar level was high.The patient was reportedly hospitalized for nine days and was discharged.The reporter alleged the patient was experiencing hallucinations on the date of discharge.The healthcare provider believed the hallucinations were from the pain medications.The patient was reportedly taken off the medications and the patient's hallucinations "grew worse." "a few days later," the patient was readmitted to the hospital.The patient had blood work completed and it was determined the patient reportedly had a "blood infection/e.Coli" and the patient was treated with unspecified iv antibiotics.After the antibiotics, the alleged hallucinations improved until (b)(6) 2021.On (b)(6) 2021, the patient was provided one more unit of blood and the hallucinations recurred.The healthcare providers believed the hallucinations were from the patient's stent in her kidney.The patient's current condition is reportedly "stable" and "at home recovering." examples of additional information requested but not provided at this time include: meter to laboratory comparison inr results.The type of antibiotics the patient received.

• 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: 13110003
• MDR Text Key: 285064669
• Report Number: 1823260-2021-03909
• 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: K170960
• 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: 12/29/2021

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 Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/29/2021
• 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: "SACUBITRIL/VALFARTAN 24/26 MG"; ALBUTEROL "HFA" 90 MCG; AMLODIPINE 5 MG; ATORVASTATIN 40 MG; BREO ELLIPTA 100/25 MCG; CALCITRIOL 0.25 MCG; CARVEDILOL 25 MG; DULOXETINE 60 MG; DUPROPION 150 MG; EZETIMIBE 10 MG; INSULIN; NITROGLYCERIN; SPIRIVA TIOTROPIUM 18 MCG; TORSEMIDE 10 MG; UNSPECIFIED IV ANTIBIOTICS; WARFARIN
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female