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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME TEST STRIPS
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ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME TEST STRIPS Back to Search Results
Catalog Number 04625374160
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/09/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
A trainer was working with the customer and they received questionable results from coaguchek xs meter serial number (b)(4).The results were 5.5 inr, 3.9 inr, and 4.1 inr.The tests were performed immediately after each other and a new finger was used for each test.No actions were taken based on the results and there was no allegation of an adverse event.The customer's therapeutic range was 2.0-3.0 inr.The customer had no hematocrit issues, no anemia, no polycythemia, no heparin therapy, no direct thrombin, no antiphospholipid antibodies, and no lupus.The customer had no change in dose, no new meds, no new illnesses, no diet change, and no bleeding or bruising.The suspect meter and strips were requested to be returned for investigation.Replacement product was sent.
 
Manufacturer Narrative
The customer returned the meter and any empty vial of strips for investigation.The strips were not able to be investigated due to the vial being empty.The returned meter was tested in comparison to a retention meter and master lot strips.Human blood samples from warfarin donors were used.Donor 1 inr: 2.1 inr.Donor 2 inr: 2.2 inr.Donor 1 hct: 52%.Donor 2 hct: 46%.Testing results: donor 1: retention meter with masterlot strips: 2.1 inr.Customer meter with masterlot strips: 2.1 inr.Donor 2: retention meter with masterlot strips: 2.3 inr.Customer meter with masterlot strips: 2.2 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned and the retention material meet the specifications.Meter memory was analyzed and verified the alleged results were present.Relevant retention test strips (lot 26683421) were tested in comparison with the current master lot.For this purpose two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention samples were acceptable.Retention material performed as specified.
 
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Brand Name
COAGUCHEK ® XS SYSTEM
Type of Device
PROTHROMBIN TIME TEST STRIPS
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key7376825
MDR Text Key104028527
Report Number1823260-2018-00932
Device Sequence Number1
Product Code GJS
Combination Product (y/n)N
PMA/PMN Number
K062925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 04/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2019
Device Catalogue Number04625374160
Device Lot Number26683421
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AMBIEN; CERIVASTATIN; LEVOTHYROXINE; METOPROLOL; WELLBUTRIN
Patient Age45 YR
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