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

Catalog Number	04625374160
Medical Device Problem Codes	No Device Output (1435); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The coaguchek xs pt test 6 strip lot number is 85848923, and the expiration date is 31-oct-2026.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 meter and test strips were 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.The customer also reported receiving an error 6 and an error 7.Error messages are designed as fail-safes to prevent the device from producing a result when certain operating conditions aren't met.Per the device's product labeling, error 6 is a test strip interference error.Per the device's product labeling, error 7 is a measurement error caused by the blood sample.
Event or Problem Description
There was an allegation of a questionable inr result using the coaguchek xs pt test 6 strip with the coaguchek xs pst care kit for 1 individual.The initial result was 1.6 inr.A second result in less than a 4-hour window was 2.5 inr.The customer's therapeutic inr range is 2.0 inr to 3.0 inr.

• 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 46250-0457
• MDR Report Key: 25257319
• Report Number: 1823260-2026-02033
• Device Sequence Number: 13397149
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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: 85848923
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 06/18/2026
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Weight: 99 KG