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

Catalog Number 03666794001

Device Problems No Device Output (1435); Output Problem (3005)

Patient Problem Hemorrhagic Stroke (4417)

Event Date 10/11/2022

Event Type  Injury  

Manufacturer Narrative

The meter was requested for investigation.A follow-up report will be submitted when the meter is returned.The test strips that were in use at the time of the events are no longer available.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.Occupation is patient/consumer (patient's wife).

Event Description

It was alleged that a patient had a stroke on (b)(6) 2022 and a second stroke at the end of (b)(6) 2022.A delay in testing with the coaguchek xs meter may have contributed to the alleged events.The patient's therapeutic range is reported to be 2.5 - 3.5 inr with an alleged testing frequency of every 2 weeks.The patient's wife called on (b)(6) 2023 alleging that they received an error on the meter, but didn't know what else was on the screen.The patient's wife reported that nothing happened after applying the blood to the test strip and seeing the countdown.The meter allegedly goes into a set mode when turned on.When reviewing test strip dosing with the patient's wife, she alleged that it may have taken longer than 15 seconds to stick the patient's finger and apply blood to the test strip.The wife reported that the test strip channel wasn't filled and she was advised to fill it.The patient's wife then described the patient's alleged stroke events.Event 1: it was reported that on (b)(6) 2022, the patient's mouth dropped, he couldn't speak a sentence, he couldn't smile, he had slurred speech, and he couldn't raise his arms.The patient reportedly went to the hospital.When his inr was tested in the hospital, it was allegedly > 11.8 inr.The patient was reportedly given warfarin and lovenox.It was reported that a computer-aided tomography (cat) scan was performed on the patient's brain and bleeding was found in the brain.The patient was allegedly diagnosed with a stroke.The patient's cardiac medication was reportedly adjusted to stop the bleeding.No meter results were provided prior to this event.It was reported that the patient's inr was tested throughout his time in the hospital, but these results are unknown.The wife reported they got the patient's inr back to normal.The patient was reportedly released from the hospital during the first or second week of (b)(6) 2022.Event 2: at the end of (b)(6) 2022, it was reported that the patient tried to test with the meter and an error message was received.The error messages received are unknown.It was alleged that the patient again had the same symptoms of mouth dropping, being unable to speak sentences, not being able to smile, having slurred speech, and being unable to raise his arms.The patient was reportedly admitted to the hospital.While in the hospital, the patient's inr was reportedly tested and the first result was 1.2 inr.Additional inr measurements performed at the hospital are not known.It was alleged that while in the hospital, the patient's warfarin was adjusted and he was provided lovenox for treatment.The patient allegedly received a cat scan and magnetic resonance imaging (mri).It was alleged that the whole right side of the patient's brain was bleeding.The patient was reportedly diagnosed with a stroke.The patient was reportedly released from the hospital on (b)(6) 2022 and went to a rehabilitation facility after that.The patient was reportedly in rehabilitation until (b)(6) 2023.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

No material was returned for investigation.The customer stated it may have taken longer than 15 seconds to dose the test strip after the fingerstick.Per product labeling: ".After sticking your finger, you have 15 seconds to apply blood to the test strip.If it takes longer to form a good drop of blood, lance a different finger for the test." the investigation could not identify a product problem.

• 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: 16357454
• MDR Text Key: 309370024
• Report Number: 1823260-2023-00427
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• 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,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2023
• 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
• Patient Outcome(s): Hospitalization
• Patient Sex: Male