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	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable results from a coaguchek pro meter.At 6:51 am, the initial result from the patient meter (serial number (b)(6) was 1.3 inr.At 9:07 am, the patient went to the doctor's office and the result from the professional meter was 3.3 inr.The retest result using the patient's meter and the test strips from the doctor's office was 3.1 inr.The therapeutic range was 2.5-3.5 inr and the patient tests weekly.The patient had a dietary change of eating oranges.
Additional Manufacturer Narrative
The coaguchek professional meter serial number was (b)(6).Quality controls were tested on the pro meter and passed.No product has 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.

• 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: 19011061
• Report Number: 1823260-2024-00968
• Device Sequence Number: 3809547
• Product Code: GJS
• UDI-Device Identifier: 00365702128101
• UDI-Public: 00365702128101
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2024

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: 03/31/2025
• Device Catalogue Number: 04625315160
• Device Lot Number: 73389513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 04/01/2024
• 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: CLARITIN; CRESTOR; FLOMAX; GLIPIZIDE; JANTOVEN; JANUVIA; JARDIANCE; LASIX; MECLIZINE; METFORMIN; METOPROLOL; MULTAQ; NORCO; TOTAL BEETS; TRICOR
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 120 KG