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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 Problems Device Difficult to Setup or Prepare (1487); Incorrect, Inadequate or Imprecise Result or Readings (1535); Lack of Maintenance Documentation or Guidelines (2971)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2023
Event Type  malfunction  
Manufacturer Narrative
Initial reporter occupation is patient/consumer.The meter test strips were requested for investigation.The meter was returned for investigation.The investigation is ongoing.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.Customer received an error 5.The error 5 was caused by not enough blood being applied to the test strip to complete the test.
 
Event Description
The customer complained of discrepant inr results with coaguchek xs meter serial number (b)(6).At 11:11 am, the repeat meter result was 2.9 inr.The customer repeated the test and the result was 5.7 inr.Customer's therapeutic range is 2.5-3.5 inr.The customer tests every two weeks.
 
Manufacturer Narrative
The returned meter was measured with the retention test strips 64708110 in comparison to the current test strip master lot.For this purpose two human blood samples from marcumar donors and internal reference meters were used.Donor 1 hct: 43%, donor 2 hct: 40%.Testing results: donor #1: retention meter and master lot strips: 4.0 inr, returned meter and retention strips: 3.7 inr.Donor #2: retention meter and master lot strips: 3.0 inr, returned meter and retention strips: 2.8 inr.All inr values were within the specified target ranges, confirming the functionality of the coaguchek measuring system.No error messages occurred.Returned customer material and retention material complies with specification.
 
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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
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
amy nelson
9115 hague road
na
indianapolis, IN 46250
3174767531
MDR Report Key16997366
MDR Text Key315922493
Report Number1823260-2023-01738
Device Sequence Number1
Product Code GJS
UDI-Device Identifier00365702127104
UDI-Public00365702127104
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/31/2024
Device Catalogue Number04625374160
Device Lot Number64708121
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received06/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ANTIBIOTIC SMC/TNTDIESTAM.; ASPIRIN.; GABAPENTIN.; LASIX.; METOPROLOL.; RAMIPRIL.; ROSUVASTATIN.; TAMSULOSIN.; WARFARIN.
Patient Age80 YR
Patient SexMale
Patient Weight75 KG
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