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

Catalog Number 04625374160

Device Problems High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ischemia Stroke (4418)

Event Date 11/04/2023

Event Type  Injury  

Event Description

We received an allegation that a coaguchek xs meter may have contributed to a patient's alleged stroke caused by a blood clot in the brain and that the same meter gave a questionable inr result when the result was compared with an unknown laboratory method.On (b)(6) 2023, the meter result was reportedly 2.6 inr.On (b)(6) 2023, the patient reportedly had stroke symptoms: the left side of her body was partially paralyzed, slurred speech, and was unable to move her left arm.She reportedly went to the emergency room (er).Upon arrival at the hospital, the laboratory result from an unknown method was reportedly 1.2 inr.Magnetic resonance imaging (mri) and computed tomography (ct) scans were reportedly performed.The results allegedly showed a blood clot in the brain (the patient did not know which side).The patient reportedly had surgery to remove the blood clot.The patient was allegedly on a heparin drip and warfarin while in the hospital.She was reportedly on 3 mg of warfarin before the blood clot occurred and was reportedly on 14 mg of warfarin when she left the hospital.The patient was allegedly in the hospital for 12 days and reportedly did not have any lasting effects from the stroke.The patient reportedly had only one blood clot in the brain and no other blood clots were found.On (b)(6) 2023: the result from an unknown laboratory method at 10:00 am using a venous blood sample was reportedly 4.1 inr.The meter result at 11:00 am using a fingerstick blood sample was reportedly 5.6 inr.The patient's warfarin dose was reportedly lowered from 14 mg to 11 mg daily based on the laboratory result.The patient's therapeutic range is reportedly 2.0 to 3.0 inr with an alleged testing frequency of weekly.The patient is reportedly currently "feeling good." this mdr is being submitted in an abundance of caution.

Manufacturer Narrative

The coaguchek xs meter serial number was (b)(6).The products were requested for investigation.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and the results have passed the internal inspection.Section e3 - occupation: patient/consumer.

Manufacturer Narrative

The customer's products were not received for investigation.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." the investigation did not identify a product problem.

• 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: 18377282
• MDR Text Key: 331184016
• Report Number: 1823260-2023-04167
• 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,Followup
• Report Date: 01/10/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 04625374160
• Device Lot Number: 64708121
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 01/10/2024
• 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): Required Intervention; Hospitalization
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 125 KG