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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH COAGUCHEK XS PT TEST; TEST, TIME, PROTHROMBIN
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ROCHE DIAGNOSTICS GMBH COAGUCHEK XS PT TEST; TEST, TIME, PROTHROMBIN Back to Search Results
Catalog Number 04625374
Device Problems Nonstandard Device (1420); High Test Results (2457)
Patient Problem Test Result (2695)
Event Date 08/05/2018
Event Type  malfunction  
Event Description
On (b)(6) 2018, i got an unusually high inr result 4.0.As a result i contacted my dr, took lower doses of warfarin (most likely unnecessary) and it took numerous extra tests over the course of more than a month to get back to my normal range between 2-3.I eventually received an urgent medical device correction notice from coaguchek (approx september 22, 2018) regarding defective / affected test strips.The test strip i used for that unusually high result was among those listed as affected lot 28632021.Most of the test strips i had remaining (as yet unused) were from affected lots.I then received add'l notifications and a batch of new test strips that had lot numbers that were among those listed as "affected." i assume that my insurance carrier was billed for test strips sent to me including those from affected lots before and after notification.I believe that no one, including my insurance carrier should have to pay for defective products.
 
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Brand Name
COAGUCHEK XS PT TEST
Type of Device
TEST, TIME, PROTHROMBIN
Manufacturer (Section D)
ROCHE DIAGNOSTICS GMBH
MDR Report Key8125064
MDR Text Key129345011
Report NumberMW5081783
Device Sequence Number1
Product Code GJS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date06/30/2019
Device Catalogue Number04625374
Device Lot Number28632021
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age60 YR
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