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

Model Number 04837738 (REF)

Device Problems Incorrect Measurement (1383); Calibration Problem (2890)

Patient Problems Pulmonary Embolism (1498); Fatigue (1849); Pain (1994); Respiratory Distress (2045); Swelling (2091); Weakness (2145); Ambulation Difficulties (2544)

Event Date 11/26/2018

Event Type  Injury  

Event Description

I received the new test strips following the coaguchek recall.I had gradually become weak, fatigued, swollen, and in pain for 3 weeks.My dr sent me for blood work showing my inr was 1.9 even though the device said i was 2.6.My inr had been low for several weeks at that point with the test strips being calibrated incorrectly.On the 25th i developed severe back pain.In the middle of the night it became so severe i could not walk and had to be taken to the hospital.Tests showed i had a recent pulmonary embolism.I had an episode where i could not breathe and required oxygen.I could not walk for several days until my inr finally hit 3.1 on the 30th.I wanted to test the new test strips to avoid another relapse.The same day i got the 3.1 result, the device said i was at 3.7.Pts are in danger and i pray no one else is affected by this company.

• Brand Name: COAGUCHEK XS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 8133722
• MDR Text Key: 129576533
• Report Number: MW5081846
• 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
• Type of Report: Initial
• Report Date: 12/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 04837738 (REF)
• Device Catalogue Number: 04015630945689 (GTIN)
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Weight: 82