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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 Degraded (1153); Non Reproducible Results (4029)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2024
Event Type  malfunction  
Manufacturer Narrative
The meter and test strips have been requested for investigation.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.The investigation did not identify a product problem.The cause of the event could not be determined.
 
Event Description
We received an allegation of questionable inr result with coaguchek xs meter serial number (b)(6).At 3:58 pm, the meter result was 4.0 inr using test strip lot 70302123.Customer stated the test strip came apart upon removal from the meter after the test.At 4:02 pm, the meter result using test strip lot 72704121 with expiration date 31-mar-2025 and the same finger as the initial test was 3.0 inr.At 4:12 pm, the meter result using test strip lot 72704121 and a new finger was 3.0 inr.The customer's therapeutic range is 2.0-3.0 inr.Customer tests on a bi-weekly basis.
 
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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
sandhofer strasse 116
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
amy nelson
9115 hague road
indianapolis, IN 46250
MDR Report Key19215308
MDR Text Key341589575
Report Number1823260-2024-01323
Device Sequence Number1
Product Code GJS
UDI-Device Identifier00365702127104
UDI-Public00365702127104
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K062925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/30/2024
1 Device was Involved in the Event
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 Catalogue Number04625374160
Device Lot Number70302123
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/05/2024
Initial Date FDA Received04/30/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
METOPROLOL; ROSUVASTATIN; WARFARIN
Patient Age54 YR
Patient SexFemale
Patient Weight77 KG
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