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

Catalog Number 04625374160

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2019

Event Type  malfunction  

Manufacturer Narrative

The patient's product was requested for investigation and replacement product was sent to the patient.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.Relevant retention test strips (lot 417474 and lot 409638) were tested in comparison with the master lot coaguchek xs pt.For this purpose two human blood samples from marcumar donors and two internal reference meters were used.Retention samples were acceptable.No error messages occurred.The occupation is lay user/patient.

Event Description

The initial reporter stated he received discrepant results when testing with coaguchek xs meter serial number (b)(4) and test strip lot numbers 40963821 and 41747423.The reporter stated the first complained measurement with test strip lot number 40963821 was one to two weeks prior to 02-jan-2020.The specific date of the event is unknown.One to two weeks prior to 02-jan-2020, a sample from the patient was tested using the meter and test strip lot 40963821, resulting with a value of 4.4 inr.Within a few minutes, a sample from the patient was tested using the meter and same test strip lot, resulting with a value of 3.2 inr.On (b)(6) 2020, a sample from the patient was tested in the hospital laboratory using synthasil reagent with isi 1.0 and geometric mean 11.5 on an il top 500 analyzer, resulting with a value of 4.6 inr.The patient asked the laboratory to re-check and the next measurement with the laboratory method was 4.78 inr.Within 4 hours of the laboratory tests, the patient tested a sample on the meter using test strip lot 40963821, resulting with a value of 3.3 inr.The patient also tested a sample on the meter using test strip lot 41747423 within 4 hours of laboratory testing and the result was 3.2 inr.The patient's therapeutic range is 2.0 - 3.0 inr.The patient's testing frequency is almost daily.

• 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: 9635652
• MDR Text Key: 217665371
• Report Number: 1823260-2020-00207
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2020

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: 01/31/2021
• Device Catalogue Number: 04625374160
• Device Lot Number: 40963821, 41747423
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/28/2020
• 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: 57 YR
• Patient Weight: 84