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

Catalog Number 04625315160

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer stated that they received erroneous results when testing one patient with coaguchek xs pro meter serial number (b)(4).A sample from the patient was tested on the meter, resulting as 1.7 inr.Within minutes, a sample from a different finger of the patient was tested on the meter, resulting as 2.5 inr.No adverse events were alleged to have occurred with the patient.The customer did not believe the patient was treated based on the meter results.The patient's current condition is stable.The patient's therapeutic range is 1.8 - 2.8 inr.The patient is tested twice per week.The patient did not have anemia or antiphospholipid antibodies.The patient did not have a special or unusual diet.The customer's product was requested for investigation and replacement product was sent to the customer.Relevant retention test strips (lot 272163) were tested in comparison with the current master lot.For this purpose two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention samples were acceptable.The customer's meter was returned for investigation.The returned meter and masterlot strips were tested in comparison to a retention meter and masterlot strips.Human blood samples from warfarin donors were used.Donor 1 inr: 2.7 inr.Donor 2 inr: 2.2 inr.Donor 1 hct: 38%.Donor 2 hct: 48%.Testing results: donor 1: retention meter with masterlot strips: 2.7 inr; customer meter with masterlot strips: 2.7 inr.Donor 2: retention meter with masterlot strips: 2.2 inr; customer meter with masterlot strips: 2.2 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.The patient is on an antibiotic.Antibiotics taken in combination with warfarin can influence inr values.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7652001
• MDR Text Key: 113018566
• Report Number: 1823260-2018-02154
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 04625315160
• Device Lot Number: 27216311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2018
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR