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

Lot Number 27216523

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

For about 4 months, i was getting false readings on my coaguchek inr home test machine.I called roche a few times to tell them of the high readings i was getting.I sent one machine back and they sent me another machine.Still high readings.I would home-test and get a reading of 4.9 and within a short time, go for a vein draw and get a reading of 3.4.This is an example.The vein draw was about 1-2 hours after the home test.They told me i must be doing the test wrong.Took my machine to my cardiologist's office and had them watch me doing the test.I was doing it correctly.I finally made the decision that i was just going to go to the lab for the vein draw as i was having to do that every time anyway.I sent the second machine back.Roche would never listen and insisted it was me and not the machine or strips.I did not want to take a chance of getting a stroke or worse, with an inaccurate reading time and time again.I still have the boxes with the lot numbers and they are not on the list that you have here.They are lot #27216523 and #27216321.I am glad to see this as i think there are big problems with these strips.I tried to get back in on the alere website so i could give you the exact results of the home test compared to the vein draw but since i discontinued the use of the home test, they have locked me out.Thought you should know this.Thanks.

• Brand Name: COAGUCHEK XS PT TEST STRIPS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 8071144
• MDR Text Key: 127541282
• Report Number: MW5081272
• 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: Other
• Type of Report: Initial
• Report Date: 11/07/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 27216523
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 64