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 Cardiac Enzyme Elevation (1838); Gastrointestinal Hemorrhage (4476)

Event Date 07/31/2019

Event Type  Injury  

Event Description

It was alleged that while using coaguchek xs meter serial number (b)(6), a patient who is on anticoagulation to reduce the risk of clot formation due to antiphospholipid antibody syndrome had in late (b)(6) 2019 significant gastrointestinal bleeding which required hospitalization and transfusion.Reportedly, the patient was also treated for a non-st elevation myocardial infarction following this incident.At the hospital, on approximately (b)(6) 2019 it was reported that the patient had a laboratory draw with an inr in the 7 range and a low hemoglobin.Reportedly, this delayed a planned angiogram.Reportedly, the patient was hospitalized for approximately 5 days and received 2 units of blood.It was reported that previous to the event his coaguchek device indicated a subtherapeutic inr, (b)(6) 2019 1.4 inr, (b)(6) 2019 1.3 inr, (b)(6) 2019 2.3 inr.The patient¿s therapeutic range was reported to be 3.0-4.0 inr.It is reported that he increased his warfarin an unknown amount any time the inr was below 3.0 inr.Reportedly the patient¿s regular testing interval is weekly when the inr is stable.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

Section e3: occupation is patient/consumer.The reporter's meter was provided for investigation where it was tested using retention test strips and retention controls.Testing results (qc range = 2.3 - 3.5 inr): qc 1: 2.8 inr, qc 2: 2.8 inr, qc 3: 2.9 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.Per product labeling: "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.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17513450
• MDR Text Key: 320916689
• Report Number: 1823260-2023-02598
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (y/n): Y
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/11/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: METFORMIN.; TOUJEO INSULIN.; TRULICITY.; WARFARIN.
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 136 KG