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

Catalog Number 04625374160

Device Problems No Device Output (1435); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2022

Event Type  Injury  

Manufacturer Narrative

The reporter's meter and test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.2 inr, qc 2: 5.3 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.The results alleged by the customer were observed in the meter¿s patient result memory.Multiple occurrences of the alleged error messages were present in the meter memory.Product labeling for the device states: you may see the following error messages while using the coaguchek xs meter.If you see an error message, first try to correct the problem using the solution described below.If the problem persists, call roche customer support center at (b)(6), monday through friday from 7 am to 11 pm est.Per product labeling for the device for error 5: error applying blood to the test strip.Turn the meter off and remove the test strip.Repeat the test using a new test strip and blood taken from a new fingerstick from a different finger.Per product labeling for the device for error 8: an error occurred during the internal diagnostic test.Turn the meter off and remove the batteries.Wait at least 1 minute before re-inserting the batteries into the battery compartment.Re-set the date and time as described in the meter setup section of this manual.Caution: the date and time must be set correctly.Repeat the test.If you see the same error message again, the meter has a defect.Call the roche customer support center at (b)(6).The patient had antiphospholipid antibodies (apas), product labeling states: the presence of anti-phospholipid antibodies (apas) such as lupus antibodies (la) may lead to prolonged clotting times, i.E., they may cause false-high inr values.If you have or suspect that you have apas, discontinue testing until you discuss with your physician.Occupation was patient/consumer (patient's daughter).

Event Description

The initial reporter alleged "something was wrong" with the coaguchek xs meter and mentioned a bleeding event for the patient.On (b)(6) 2022 at 3:00 pm, the patient allegedly called her daughter and said her nose had been bleeding since 10:30 am.The patient's daughter took the patient to the hospital and she was then admitted.At 4:00 pm, the result from the hospital laboratory using an unknown reagent was reported to be 6.6 inr.The patient was allegedly treated with afrin nasal spray, which stopped the bleeding in her nose.The patient was allegedly given a vitamin k shot and two bags of fresh frozen plasma.It was requested but not known if the patient received blood transfusions.The patient allegedly did not require surgical intervention.Allegedly, the patient's doctor advised the patient that her high inr levels caused the nosebleed and hospitalization.The patient allegedly coughed up a huge blood clot that was in her throat.It was believed the blood clot had come from her nose.The patient alleged the meter had not worked for three weeks prior to the hospitalization on (b)(6) 2022.It was requested but not known if the patient sought alternate testing.The patient reportedly continued taking her normal dose of 4.5 mg of warfarin daily.On (b)(6) 2022, it was clarified the issue with the meter was error 5 and error 8.The reporter stated the batteries were replaced, then the meter displayed "set" and "date flash".This issue was resolved during the call with technical support.On an unknown date, the patient was released from the hospital.The patient allegedly has a "huge headache", is tired, and sleeps a lot, but is stable.The patient's therapeutic range was 2.5-3.5 inr and the patient tests weekly.This mdr is being submitted in an abundance of caution.

• 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: 15372295
• MDR Text Key: 299451557
• Report Number: 1823260-2022-02747
• 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: 09/07/2022

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: 07/31/2023
• Device Catalogue Number: 04625374160
• Device Lot Number: 58526222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 09/07/2022
• 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; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 61 KG