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

Catalog Number 04625374160

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Ischemia Stroke (4418)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

The test strips are no longer available for investigation.The meter has been requested for return and has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.  the customer initially called to set the date and time on the meter after replacing the batteries.During the call, the customer was assisted to perform this procedure from the user manual.

Event Description

We received an allegation that a coaguchekxs meter with serial number (b)(4) may have contributed to a patient's stroke.  the patient initially called because he received a "set + date" message after replacing the batteries of the meter.During the call, the patient mentioned that he had a stroke around the end of (b)(6) 2018.On (b)(6) 2018, the reported meter result according to the patient's logbook was 2.1 inr.On (b)(6) 2018, the reported meter result according to the patient's logbook was 2.0 inr.The patient stated that the stroke occurred at the end of (b)(6) 2018.The patient stated that he was at his friend's house and his left arm was tingly, his fingers were bent, he was feeling bad and couldn't speak right.His friend reportedly took him to a hospital where it was determined that he had a stroke.The laboratory result at the hospital using an unknown laboratory method was reportedly 1.1 inr.The doctor reportedly said that the stroke was caused by the low inr.The patient stated that he does not remember when he last tested on his meter prior to the stroke.The patient stated that he does not remember the medical treatment he received, what his inr was throughout the hospital stay, if any imaging was done and if he stayed in the intensive care unit (icu).The patient stated that the stroke was an ischemic stroke.The therapeutic range was reported to be 2.0 - 3.0 inr and the interval of testing is once a week.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

The returned meter was tested with retention strips and a high-level control sample.Testing results (qc range = 4.1¿ 6.8 inr): qc 1: 5.2 inr; qc 2: 5.3 inr; qc 3: 5.3 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The results alleged by the customer were observed in the meter¿s patient result memory.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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15371809
• MDR Text Key: 299455668
• Report Number: 1823260-2022-02746
• 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,Followup
• Report Date: 10/20/2022

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 Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 10/20/2022
• 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: AMLODIPINE; ASPIRIN; B12; GLIPIZIDE; HYDROCHLOROTHIAZIDE; LISINOPRIL; METFORMIN; SIMVASTATIN; WARFARIN
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 102 KG