MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH COAGUCHEK XS STRIPS; TEST, TIME, PROTHROMBIN

Model Number 04837738

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

Patient Problems Apnea (1720); Death (1802); Pain (1994); Thrombosis (2100); Vascular System (Circulation), Impaired (2572)

Event Date 11/15/2018

Event Type  Death  

Event Description

My husband used the coaguchek xs to test for his warfarin levels.On (b)(6) 2018, he reported "and" number of 6.3.The dr adjusted his dosing based on these results.On (b)(6), he was taken to the emergency room after pain in both legs.The inr from blood taken at that time was 1.8.The dr performed an ultrasound and admitted him to the hosp.He had dvt of left leg; clot in right artery.The strips he was using were gtin (b)(4), lot 27216421.He used 3 of these strips prior to the hospitalization: readings were (1.8, 3.9, 6.3).One strip was rejected.He did not use the rest after returning from hosp and waited for new strips.He was in the hosp from (b)(6) 2018.On (b)(6) 2018 he went to bed early complaining he was not feeling well.He was snoring very loudly and suddenly stopped.I checked his breathing and he was not.My son immediately started chest compression and called 911.He was pronounced dead at the hosp early in the morning on (b)(6) 2018.

• Brand Name: COAGUCHEK XS STRIPS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 8252766
• MDR Text Key: 133339693
• Report Number: MW5083114
• Device Sequence Number: 2
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/11/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2019
• Device Model Number: 04837738
• Device Lot Number: 27216421
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 57 YR
• Patient Weight: 68