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 Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained that prior to testing a patient they received a temperature error on a coaguchek xs meter.The meter serial number was (b)(4).The customer resolved the error by removing the batteries for a minute and re-inserting the batteries.Following the meter resetting itself, the customer complained of questionable inr results for 1 patient.At 10:15 am the result from the meter was 1.8 inr.At 10:16 am the result from the meter was 1.2 inr.Testing was performed using the same finger.The patient's therapeutic range was not provided.The customer stated that they she questioned the accuracy of the meter and did not report the patient's results.There is no allegation of an adverse event.The patient is on a special cardiac diet.The patient had no hematocrit concerns, no antiphospholipid antibodies, no direct thrombin inhibitors, no change in warfarin dosage, and no new illnesses.The patient has been on an increase in potassium along with also taking a heart medicine.The suspect product was requested to be returned for investigation.Replacement product was sent.The returned meter and strips were tested in comparison to a retention meter and masterlot strips.Two human blood samples from warfarin donors were measured.Donor 1 inr: 2.3 inr.Donor 2 inr: 2.3 inr.Donor 1 hct: 35%.Donor 2 hct: 36%.Donor 1: retention meter with masterlot strips: 2.3 inr.Customer meter with customer strips: 2.3 inr.Donor 2: retention meter with masterlot strips: 2.3 inr.Customer meter with customer strips: 2.2 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned and the retention material meet the specifications.No information was provided in the complaint case that would point to a cause for the result discrepancy.Alleged results by the customer were observed in the meter¿s patient result memory, but date could not be confirmed as the customer did not have the date and time set correctly.Relevant retention test strips (lot 18686611) 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 investigation was unable to find a definitive root cause for this event.

• 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: 7425885
• MDR Text Key: 105883769
• Report Number: 1823260-2018-01142
• 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: 04/12/2018

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: Nurse
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 04625315160
• Device Lot Number: 18686611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/12/2018
• 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