MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH COAGUCHECK; TEST, TIME, PROTHROMBIN

Device Problems High Readings (2459); Compatibility Problem (2960)

Patient Problems Stroke/CVA (1770); Quadriplegia (2449)

Event Date 05/10/2022

Event Type  Injury  

Event Description

Two years ago my significant other (b)(6) was diagnosed with antiphospholipid syndrome after a stroke.He was sent a roche coagucheck at home inr meter to monitor his inr.He takes warfarin to prevent more strokes.(b)(6) had a massive stroke on 5/10.In er his inr was 1.6 which is far below his therapeutic range of 2.5-3.5 i administer his meds.No doses of warfarin were missed.I brought his meter to the hospital and tested it against the hospital lab results.His meter reading was almost a full point higher than the actual lab result.I called the company who supplied the meter and continues to supply the test strips and the customer service woman admitted they know the meters give falsely high inr results on antiphospholipid patients.(b)(6) is now a quadriplegic.Previously he was ambulatory and only had right arm weaknesses.Now he is wheelchair bound and can do nothing for himself.This company is providing meters to people they know can be harmed and they don't care.Fda safety report id# (b)(4).

• Brand Name: COAGUCHECK
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 14488321
• MDR Text Key: 292606266
• Report Number: MW5109850
• Device Sequence Number: 1
• 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: 05/19/2022

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?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2022
• Patient Sequence Number: 1
• Treatment: WARFARIN
• Patient Outcome(s): Disability; Hospitalization; Life Threatening
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White