MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PT TEST PST; COAGULATION TEST SYSTEM

Catalog Number 07671687070

Device Problem High Test Results (2457)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

The meter and strips were received for investigation.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.The investigation is ongoing.

Event Description

There was an allegation of questionable results from coaguchek inrange meter, serial number (b)(6), compared to a coaguchek pro ii meter.The inrange meter result was 3.2 inr.The pro ii meter result within 30 minutes was 2.2 inr.The patient¿s therapeutic range was not provided.

Manufacturer Narrative

The reporter's meter and 1 strip were provided for investigation where it was tested using retention controls.Testing results (qc range = 2.3 - 3.5 inr): qc 1: 2.9 inr (customer strip) qc 2: 2.9 inr (corresponding retention strip) qc 3.3.0 inr (corresponding retention strip) the obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The result of 3.2 inr from 27-feb-2024 mentioned by the customer was observed in the meter¿s patient result memory.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COAGUCHEK XS PT TEST PST
• Type of Device: COAGULATION TEST SYSTEM
• 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: 18946148
• MDR Text Key: 338263315
• Report Number: 1823260-2024-00826
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 07671687070
• Device Lot Number: 70302014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN; BISOPROPOL; DIHYDROCODEINE; MOVELAT GEL; OMEPRAZOLE; WARFARIN