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

Catalog Number 04625358016

Device Problem High Test Results (2457)

Patient Problems Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

The customer's meter and test strips were requested for investigation.The returned test strips were measured with the returned meter with a high level control sample.Testing results (qc range = 2.5 - 3.1 inr): qc measurement 1 = 2.7 inr.Qc measurement 2 = 2.7 inr.Qc measurement 3 = 2.7 inr.All inr values were within the specified target ranges, confirming the functionality of the coaguchek measuring system.No error messages occurred.The returned customer material and retention material comply with the specification.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: "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those 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." occupation - the occupation is patient/consumer.

Event Description

It was alleged that a patient had thrombosis in the leg while using a coaguchek inrange meter serial number (b)(4).The specific date of the event is not known.The thrombosis was allegedly detected by ultrasound in (b)(6) 2022.It was alleged the patient had pain in her leg since (b)(6) 2022 and the leg was reported to be "thick".This was alleged to be the same leg the thrombosis occurred.The patient's alleged therapeutic range is 2.0 - 2.5 inr and it was alleged the patient is not allowed to go above 2.5 inr according to the patient's doctor.The patient's testing frequency is reported to be daily.It was alleged that the patient receives a difference of 0.5 - 0.6 inr from time to time when comparing values measured on the meter to values measured in the laboratory.Specific measurement dates and values were requested, but not provided.It was alleged that the device measured high results incorrectly and therefore anticoagulation treatment of the patient was too low, leading to thrombosis.It was alleged the patient was in the hospital for only a short time.It was alleged that no treatment was provided to the patient at the hospital for the thrombosis.It was reported that the patient injected clexane 6000 at home after the detection of thrombosis and always keeps clexane at home and sometimes uses it when she cannot keep within her narrow therapeutic range.It was reported that no changes were made to the patient's anticoagulation medication dose or to the patient's therapeutic range after the event.The patient is reported to be in good health currently.The following additional information was requested, but could not be provided: the exact date of the alleged thrombosis.The exact location of the alleged thrombosis in the leg.The specific amount of time the patient was hospitalized.Information on any changes made to the patient's anticoagulation therapy regimen.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

The evaluation method and health effect - impact codes have been updated.

• 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: 13930440
• MDR Text Key: 290528664
• Report Number: 1823260-2022-00885
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625358016
• Device Lot Number: 53224913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2022
• 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: ASS; BISOPROLOL; CLEXANE; DEKRISTOL; EUTHYROX; MARCUMAR; PATHOPRAZOL; PROCORALAN; SPIRONOLACTON; TORASEMID
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 76 KG