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

Model Number XS PST

Device Problem Non Reproducible Results (4029)

Patient Problems Stroke/CVA (1770); Fall (1848); Numbness (2415)

Event Date 10/01/2022

Event Type  Injury  

Manufacturer Narrative

The meter was requested for investigation.The test strips are not available for return.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".Initial reporter occupation: patient/consumer.

Event Description

We received an allegation that the coaguchek xs meter with serial number (b)(4) may have contributed to a patient's stroke.The reporter initially called because the meter result on (b)(6) 2023 was 4.9 inr and for assistance with ordering test strips.During the call, the reporter mentioned a stroke event in (b)(6) 2022.The exact date in (b)(6) was unknown to the reporter.The reporter alleged that there were error messages on the meter prior to the stroke and the patient was unable to use the meter.The reporter allegedly could not recall what error messages she received.The reporter alleged that in (b)(6) 2022, the patient felt weird and fell.It was reported that the patient's family had to call an ambulance.The reporter allegedly could not recall the inr result in the emergency room.The patient was allegedly admitted to the hospital where a computed tomography (cat) scan was performed and it was determined the patient had a stroke in her right brain.The physician reportedly stated that the stroke could have been caused by her blood pressure being so high when she arrived at the hospital.The patient allegedly did not injure herself from the fall and her left side was numb while in the hospital.The reporter allegedly believes that a cat scan was performed instead of a magnetic resonance imaging (mri) because the patient had a heart valve.The reporter could not recall any treatments that were done while the patient was in the hospital.The reporter alleged that the dates in the meter were all incorrect and that the patient does not keep a record for comparison.The reporter does not recall what the meter result was or if there were any warfarin dose adjustments made prior to the patient's stroke.The patient was reportedly sent to rehabilitation when she was discharged from the hospital.The meter memory was reviewed on the call.The reporter alleged a result of 2.0 inr was present in the meter memory with a date of (b)(6) 2022 at 6:24 am.Reportedly, prior to the stroke, the patient was testing as often as the physician required.It was also alleged that the patient was not always doing the correct procedure while testing.The therapeutic range is 2.0-3.0 inr.The interval of testing is every two weeks.The following additional information has been requested: - whether the stroke was hemorrhagic or ischemic.- any medications or treatment the patient received.- whether the patient tested by another method when they received error messages on the meter.This mdr is being submitted with an abundance of caution.The test strip lot number was requested but not provided.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• 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: 16559830
• MDR Text Key: 311478551
• Report Number: 1823260-2023-00847
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• 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: 03/16/2023

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 Model Number: XS PST
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/16/2023
• 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: AMLODIPINE.; ASA.; ATORVASTATIN.; BACTRIM.; CARVEDILOL.; HYDRALAZINE.; SILDENAFIL.; TARVISINE.; WARFARIN.
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 91 KG