MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PT TEST 6 STRIP; PROTHROMBIN TIME TEST STRIPS

Catalog Number	04625374160
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e3: occupation is patient/consumer the meter's serial number is (b)(6).The product was requested for investigation.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.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.
Event or Problem Description
There was an allegation of questionable results from a coaguchek xs meter.At 9:59 am, the meter result was 2.3 inr.At 1:57 pm, the meter result was 3.2 inr.The patient¿s therapeutic range is 2.4 inr-2.6inr.
Additional Manufacturer Narrative
The meter was returned for investigation.The investigation examined the returned meter and found that the battery compartment revealed heavy corrosion due to a leaked battery, the meter had damage to the meter's display from being dropped, and there was contamination on the heater plate.Due to the observed damage, the meter was unable to be powered on for further testing.The investigation determined that the issue was due to the observed damage.

• Brand Name: COAGUCHEK XS PT TEST 6 STRIP
• Common Device Name: 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 25047129
• Report Number: 1823260-2026-01701
• Device Sequence Number: 18756423
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K062925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male