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 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).Device not returned.

Event Description

The customer stated that they received erroneous results when testing a patient with coaguchek xs meter serial number (b)(4).At 10:00 a.M., a sample from the patient was tested on the meter, resulting as 6.0 inr.One to two minutes later, blood from the same finger stick was tested, resulting as 4.1 inr.For the 4.1 inr value, blood was not dosed to the test strip within 15 seconds of sticking the patient's finger.At 10:05 a.M., another sample from the patient was tested on a second coaguchek meter, resulting as 4.7 inr.The customer believed the value of 4.7 inr to be accurate.No adverse events were alleged to have occurred with the patient.The patient's therapeutic range was 2 - 3 inr.The patient did not have any hematocrit issues and did not have antiphospholipid antibodies.The patient does not take heparin or direct thrombin inhibitors.The customer's product was requested for investigation and replacement product was sent to the customer.Relevant retention test strips (lot 286319) 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 was tested in comparison to a retention meter and masterlot strips.Human blood samples from warfarin donors were used.Donor 1 inr: 2.3 inr; donor 2 inr: 2.0 inr.Donor 1 hct: 50%; donor 2 hct: 42%.Testing results: donor 1: retention meter with masterlot strips: 2.3 inr; customer meter with masterlot strips: 2.3 inr.Donor 2: retention meter with masterlot strips: 2.0 inr; customer meter with masterlot strips: 2.1 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.

• 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: 7568576
• MDR Text Key: 110578063
• Report Number: 1823260-2018-01740
• 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,user faci
• Reporter Occupation: Medical Assistant
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 04625315160
• Device Lot Number: 28631911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2018
• 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