MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME TEST STRIPS

Catalog Number	03666794001
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The meter was requested for investigation.Replacement product was sent.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 patient is diagnosed with antiphospholipid antibody syndrome.Per product labeling, "the presence of anti-phospholipid antibodies (apas) such as lupus antibodies (la) may lead to prolonged clotting times, i.E., they may cause false-high inr values." 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 meter serial number: (b)(6) compared to a laboratory result using an unknown method.The meter result was 1.8 inr.The meter result within 4 hours was 2.4 inr.No medication changes were made based on the meter results.The patient¿s therapeutic range is 2.5 - 3.0inr.The patient's testing frequency is weekly.
Additional Manufacturer Narrative
The imdrf coding in this case has been updated.

• 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 46250-0457
• MDR Report Key: 18194167
• Report Number: 1823260-2023-03751
• Device Sequence Number: 7715808
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2024

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: Lay User/Patient
• Device Catalogue Number: 03666794001
• Device Lot Number: 66283721
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 01/05/2024
• 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: ROSUVASTATIN; VERAPAMIL; VITAMIN D; WARFARIN
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 125 KG