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

Catalog Number 04625374160

Device Problem Non Reproducible Results (4029)

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

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

Section e3: occupation is patient/consumer the coaguchek xs meter serial number is (b)(6).The patient used the same finger for 2 of the tests.Product labeling states: "if you need to redo a test, use a new lancet, a new test strip, and a different finger." 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.

Event Description

We received an allegation of discrepant inr results with a coaguchek xs meter.The initial result using test strip lot 65779321 (expiration 30-apr-2024) at 8:13 a.M.Was 4.9 inr.The patient re-tested using a different finger with test strip lot 68883822 (expiration 30-sep-2024) at 8:16 a.M.With a result of 2.1 inr.The patient tested again using strip lot 65779321 with the same finger as the initial test at 8:20 a.M.With a result of 2.2 inr.The patient tested again using strip lot 68883822 with the same finger as the 2nd test at 8:24 a.M.With a result of 2.2.Inr.The result of 4.9 inr is in question.The patient¿s therapeutic range is 2.0 ¿ 2.5 inr and tests bi-weekly.

• 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: 17950933
• MDR Text Key: 325914452
• Report Number: 1823260-2023-03322
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• 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: 11/02/2023

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: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 04625374160
• Device Lot Number: 65779321
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 11/02/2023
• 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: ASPIRIN; WARFARIN
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 47 KG