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

Catalog Number 03666794001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2023

Event Type  malfunction  

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 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.

Manufacturer Narrative

The imdrf coding in this case has been updated.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: 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
• MDR Text Key: 329904866
• Report Number: 1823260-2023-03751
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03666794001
• Device Lot Number: 66283721
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROSUVASTATIN; VERAPAMIL; VITAMIN D; WARFARIN
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 125 KG