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

Model Number REF 04625374

Device Problems Display or Visual Feedback Problem (1184); Nonstandard Device (1420)

Patient Problem No Information (3190)

Event Date 11/09/2018

Event Type  Injury  

Event Description

I do home inr testing.I received a letter stating strips could error on extreme results, but ok to use them if close to normal range, so i tested.Three consecutive results had low inr so dr kept increasing dose.Last test on (b)(6), result was 1.8, still below 2 so i asked for and got lab order.Lab result 2.3.I quit using.Then letter of full recall.I believe full recall should happen the first time.I wasted time, money and was lucky i did not bleed.

• Brand Name: COAGUCHEK XS PT TEST
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 8101911
• MDR Text Key: 128443525
• Report Number: MW5081591
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/20/2018

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 Expiration Date: 07/31/2019
• Device Model Number: REF 04625374
• Device Catalogue Number: GTIN. 00365702127104
• Device Lot Number: 2941523
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR