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

Catalog Number 04625315172

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

The customer¿s products have been requested for return.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.This event occurred in (b)(6).Occupation was lay user/patient.

Event Description

The initial reporter received a questionable result from coaguchek in range meter serial number (b)(4).At 2 pm, the meter result was 4.1 inr and the laboratory result using an unknown reagent was 2.6 inr.The therapeutic range was 2.5-3.0 inr.

Manufacturer Narrative

The reporter's meter and strips were returned for investigation.The returned product was measured in comparison to a retention meter and master lot strips.Testing results (qc range: 2.7-3.3 inr): qc 1: 2.9 inr, qc 2: 2.8 inr, qc 3: 2.8 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned material and the retention material meet specifications.Medwatch fields d9 and h3 have 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
• MDR Report Key: 10481583
• MDR Text Key: 224120601
• Report Number: 1823260-2020-02162
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

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: 03/31/2021
• Device Catalogue Number: 04625315172
• Device Lot Number: 42400915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 08/10/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "ANTIBIOTICS"; "VARIOUS HEART BLOOD PRESSURE MEDICATION"; WARFARIN