MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; 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	07/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not been received at this time.The serial number for the coaguchek meter is (b)(6).The office's meter serial number is (b)(6).Section e3: occupation is (b)(6).
Event or Problem Description
We received an allegation of questionable inr results for (1) patient with a coaguchek xs plus meter at their doctor's office.This mdr is to report the results obtained on the patient's coaguchek xs meter.Refer to the mdr with a1 patient identifier (b)(6) for the report on the patient's coaguchek xs.On (b)(6) 2024 at 7:06am, the patient received results 4.7 inr.On (b)(6) 2024 at 7:12am, the patient received a result of 3.7 inr.On (b)(6) 2024 at 9:45am, the patient received a result of 5.0 inr.On (b)(6) 2024 at 10:00am result at doctor's office using coaguchek xs plus meter of 5.3 inr.The patient¿s therapeutic range was provided 3.0 to 4.0 inr.

• Brand Name: COAGUCHEK ® XS SYSTEM
• 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: 19973902
• Report Number: 1823260-2024-02351
• Device Sequence Number: 12524622
• Product Code: GJS
• UDI-Device Identifier: 00365702128101
• UDI-Public: 00365702128101
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: 04625315160
• Device Lot Number: 71519022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: WARFARIN.
• Patient Sex: Unknown