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

Catalog Number 04625374160

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)

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

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation is patient/consumer.The meter and the test strips were requested for investigation.The products have not been received at this time.If the products are 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 questionable inr results for 1 patient tested with coaguchek xs meter serial number (b)(4).On (b)(6) 2022 at 10:24 a.M.The patient had an initial meter result of 8.0 inr while upon re-test at 10:35 a.M.The meter result was 3.7 inr.The patient's therapeutic range was 2.0-3.0 inr.The patient's interval of testing is twice per month.

Manufacturer Narrative

The reporter's meter was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.1 inr; qc 2: 5.1 inr; qc 3: 5.1 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16069380
• MDR Text Key: 308393270
• Report Number: 1823260-2022-04230
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

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: 05/31/2023
• Device Catalogue Number: 04625374160
• Device Lot Number: 57790221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/27/2023
• 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: FUROSEMIDE; KEPPRA; OMEPRAZOLE; OTC VITAMIN C SUPPLEMENT (SAM'S CLUB BRAND); POTASSIUM CL MICRO; RAMIPRIL; SOTALOL; WARFARIN
• Patient Age: 79 YR
• Patient Sex: Male