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

Catalog Number 04625374160

Device Problems Improper or Incorrect Procedure or Method (2017); High Test Results (2457)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/03/2022

Event Type  Injury  

Event Description

It was alleged that a patient had discrepant results and a nosebleed that required medical treatment when using coaguchek xs meter serial number (b)(4).It was alleged the patient's nosebleed started and then he proceeded to take the following inr measurement with his meter: at 4:30 a.M.On (b)(6) 2022, the meter measurement was 2.9 inr.It was alleged that there was an issue with sample collection and mentioned: "it was slow and took longer than usual." the patient then reportedly went to the hospital.At 5:30 a.M.On (b)(6) 2022, a venous sample was collected from the patient and tested in the laboratory using an unknown method allegedly resulting in a value of 3.9 inr.At the hospital, the patient was reportedly given an inhaler for treatment and the patient's nose was packed by a physician in the emergency room.The patient has a reported therapeutic range of less than 3 inr.The patient's testing frequency is reported to be once per week.

Manufacturer Narrative

The customer's meter and test strips were requested for investigation and replacement product was sent to the customer.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 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: 5.2 inr, qc 3: 5.2 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.Per product labeling: "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.Higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods." per product labeling: "the action of oral anticoagulants (coumarin derivatives) can be increased or weakened when other medication is taken simultaneously (e.G.Antibiotics, but also prescription-free medication like pain relievers, antirheumatic medication and medication against influenza).This, in turn, can also lead to either an increase or a decrease in prothrombin time (inr).If other medication is taken, it is recommended that the prothrombin time be checked more frequently and that the anticoagulant dose be subsequently adjusted.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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14282273
• MDR Text Key: 290693782
• Report Number: 1823260-2022-01269
• 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: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 04625374160
• Device Lot Number: 54974524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Date Manufacturer Received: 04/04/2022
• 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: COREG; MACROBID; MULTI VITAMINS; POTASSIUM; WARFARIN; XTANDI
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 67 KG