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

Catalog Number 04625315160

Device Problems Misassembly by Users (3133); Non Reproducible Results (4029)

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

Event Date 10/30/2023

Event Type  malfunction  

Event Description

We received an allegation of questionable inr results for 1 patient tested on a coaguchek xs meter compared to another coaguchek xs meter at a different facility (coagulation clinic).At 10:25 am the patient was tested in the pain management clinic and received a meter result of 1.0 inr.The patient was then tested in a coagulation clinic in the same building and received a meter result of 1.9 inr.The time difference between the test measurements was within minutes.The physician believed that 1.9 inr was the correct result.The patient¿s therapeutic range was not provided.Reportedly, the result of 1.9 inr was alleged to be outside the patient's therapeutic range.

Manufacturer Narrative

The coaguchek xs meter serial number used at the pain management clinic was (b)(6).The reporter stated that the meter was cleaned due to some minor contamination.The test strips were requested for investigation.The product has not 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.

Manufacturer Narrative

The type of investigation code was 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
• MDR Report Key: 18296331
• MDR Text Key: 330142558
• Report Number: 1823260-2023-03914
• Device Sequence Number: 1
• Product Code: GJS
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 04625315160
• Device Lot Number: 62215312
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WARFARIN
• Patient Sex: Female