MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PT TEST 2X24 STRIPS; PROTHROMBIN TIME TEST STRIPS

Catalog Number	04625315160
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable results from coaguchek xs plus meter, serial number (b)(6) and a patient's coaguchek xs meter, serial number (b)(6).At 3:30 pm the patient's meter (b)(6) result was 2.2 inr using test strip lot 76900023 with expiration date 31-oct-2025.At 3:31 pm the professional meter (b)(6) result was 2.9 inr.The patient's therapeutic range is 2.0-3.0 inr.Patient tests on a weekly basis.
Additional Manufacturer Narrative
Coaguchek xs plus serial number is (b)(6).The product has not been received for further investigation 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.
Additional Manufacturer Narrative
The reporter's test strips were provided for investigation where they were tested using retention controls and retention meter level 1 testing results (qc range = 1.0 - 1.4 inr): qc 1: 1.1 inr level 2 testing results (qc range = 2.5 - 3.7 inr): qc 2: 2.9.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.Medwatch fields d9 and h3 have been updated.

• Brand Name: COAGUCHEK XS PT TEST 2X24 STRIPS
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21804797
• Report Number: 1823260-2025-01076
• Device Sequence Number: 11830163
• Product Code: GJS
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K060978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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: Health Professional
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: 04625315160
• Device Lot Number: 78284513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 05/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STOOL SOFTENER.; WARFARIN.
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 136 KG