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	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coaguchek xs plus serial number is unknown.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.
Event or Problem Description
There was an allegation of questionable results from coaguchek xs plus meter, serial number unknown compared to a patient's coaguchek vantus meter serial number (b)(6).At 12:30 pm the coaguchek xs professional meter result was 2.6 inr.At 4:04 pm the coaguchek vantus meter result was 1.6 inr.The patient was using strip lot 77503323 with expiration 31-oct-2025.The customer's therapeutic range is 2.0-3.0 inr.Customer tests on a weekly basis.
Additional Manufacturer Narrative
The serial number of the coaguchek xs meter is (b)(6).The customer's meter and test strips were provided for investigation and were tested using retention controls.Testing results qc range level 1 = 1.0 - 1.4 inr: result: 1.3 inr.Qc range level 2 = 2.5 - 3.7 inr: result: 3.1 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot; no error messages were received.The investigation did not identify a product problem.Medwatch fields d9 and h11 (meter's serial number) 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: 21535255
• Report Number: 1823260-2025-00637
• Device Sequence Number: 20607758
• Product Code: GJS
• UDI-Device Identifier: 00365702128101
• UDI-Public: 00365702128101
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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: 07/31/2025
• Device Catalogue Number: 04625315160
• Device Lot Number: 74976511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/11/2025
• 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: ARIPIPRAZOLE; SERTRALINE; SLYND BIRTH CONTROL; WARFARIN
• Patient Age: 14 YR
• Patient Sex: Female