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

Catalog Number 04625315070

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Coagulation Disorder (1779)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

This event occurred in (b)(6).Occupation is lay user/patient the test strips were requested for investigation.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.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter (patient's daughter) wanted to check the coaguchek device with serial number: (b)(4) as the patient had been admitted to the hospital with a stroke on (b)(6) 2020.The reporter wanted to check the device as the results were displayed in %quick.The patient knows the device can read in both %quick and inr and knows how to switch between units.The results from the device prior to the event were: (b)(6) 2020: 23% q (2.9 inr) ;(b)(6) 2020: 1.8 inr; (b)(6) 2020: 29% q (2 inr) ;(b)(6) 2020: 12% q (4.3 inr); (b)(6) 2020: 26% q (2.7 inr); (b)(6) 2020: 23% q (2.9 inr).The patient's therapeutic range is 2.5 - 3.0 inr.The patient was admitted to the hospital on (b)(6) 2020 with a stroke, and was discharged on (b)(6) 2020.The patient was treated in the hospital with heparin and syntrom.Since being home, the patient is only taking syntrom.There was no allegation that incorrect results were received from the device.No meter to laboratory comparisons were made while the patient was in the hospital.On (b)(6) 2020, the patient was sent a control solution to verify the strip and meter performance.The patient's meter was tested with the current lot of strips and a different lot of strips.The results were 1.9 inr and 1.8 inr.The patient's test strips were also tested with their meter and a different meter.The results were 1.9 and 1.8 inr.All results were within the expected range.This case is being reported under an abundance of caution.

• 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: 10766245
• MDR Text Key: 216580055
• Report Number: 1823260-2020-02723
• 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: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 04625315070
• Device Lot Number: 40501312
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYNTROM
• Patient Outcome(s): Hospitalization