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

Catalog Number 04625374160

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Loss of Vision (2139); Confusion/ Disorientation (2553)

Event Date 10/19/2022

Event Type  Injury  

Event Description

We received an allegation that the coaguchekxs meter with serial number (b)(4) may have contributed to a patient's stroke.The patient initially called because they were following up on a request to return a meter as they had already received the replacement meter.During the call, the patient mentioned that they suffered a stroke.On (b)(6) 2022 at 8:30 am, the meter result was reportedly 3.4 inr.The laboratory result at 9:15 am was reportedly 2.8 inr.On (b)(6) 2022, the patient reportedly could not figure out how to use the phone and was confused but the patient just reportedly went to bed.The patient reportedly thinks that this was the time of the stroke.The patient reportedly could not see completely in the left eye on (b)(6) 2022.The patient reportedly drove to go to the eye doctor.The patient was reportedly sent by the eye doctor to the emergency room (er).The patient was reportedly diagnosed to have a stroke through magnetic resonance imaging (mri).The patient was reportedly admitted to the hospital from (b)(6) 2022 through (b)(6) 2022.The patient stated that they increased the warfarin dose in the hospital and they monitored the inr every day.The patient stated that they were not sure what caused the stroke.On (b)(6) 2022, the laboratory result was reportedly 3.5 inr.The patient declined to provide any further information.The therapeutic range was requested but not provided.This mdr is being submitted with an abundance of caution.

Manufacturer Narrative

The reporter's meter was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): (b)(6).The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.According to the meter memory, the reported meter result of 4.0 inr on (b)(6) 2022 was obtained on (b)(6) 2022.According to the meter memory, the reported meter result of 5.7 inr on (b)(6) 2022 was obtained on (b)(6) 2022.According to the meter memory, the reported meter result of 2.0 inr on (b)(6) 2022 was obtained on (b)(6) 2022.According to the meter memory, the reported meter result of 3.5 inr on (b)(6) 2022 was obtained on (b)(6) 2022.According to the meter memory, the reported meter result of 4.9 inr on (b)(6) 2022 was obtained on (b)(6) 2022.According to the meter memory, the reported meter result of 2.8 inr on (b)(6) 2022 was obtained on (b)(6) 2022.According to the meter memory, the reported meter result of 3.4 inr on (b)(6) 2022 was obtained on (b)(6) 2022.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 method uses human recombinant thromboplastin.Therefore, the comparability to tests using other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastin types.However, those higher differences between thromboplastins of different (rabbit, bovine) origin are not an issue specific for coaguchek assays.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared with several other (rabbit, bovine) laboratory methods."  the investigation did not identify a product problem.The cause of the event could not be determined.  occupation: 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15845573
• MDR Text Key: 304135033
• Report Number: 1823260-2022-03736
• 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: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 04625374160
• Device Lot Number: 60124921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2022
• Date Manufacturer Received: 10/26/2022
• 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): Other; Life Threatening; Hospitalization