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

Catalog Number 04625315172

Device Problem Non Reproducible Results (4029)

Patient Problem Hematuria (2558)

Event Date 05/22/2021

Event Type  Injury  

Manufacturer Narrative

Unique identifier (udi) #: (b)(4).The customer's meter and 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 was performed.Test strip retention samples passed the internal inspection.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter alleged an issue with coaguchek xs meter, serial number (b)(4), that occurred on (b)(6) 2021.On the night of (b)(6) 2021 or on the morning of (b)(6) 2021, a patient went to the emergency room with severe hematuria.The exact date of the event could not be provided.On (b)(6) 2021, the meter would not produce a result, and it timed out after 180 seconds without an error code.Product labeling states: " when the meter is warmed up a flashing test strip appears and the meter begins a countdown.You have 180 seconds to apply blood to the test strip." it is unknown whether the nurse or the patient attempted this test or if the patient was tested again with another method on (b)(6) 2021.On (b)(6) 2021, the meter would not produce a result, and it timed out after 180 seconds without an error code, but the nurse tried again and the meter produced a result of 3.6 inr, which was above the patient's therapeutic range indicating an elevated bleeding risk.The result 3.6 inr was not confirmed with a repetition measurement on the meter or with a comparison measurement from the laboratory at that time.It was requested, but unknown whether any therapy changes took place at that time.It was requested, but unknown if the patient received any treatment in the er.The patient's inr result at the er was not provided.The patient was admitted to the hospital on (b)(6) 2021.The hospital's laboratory result for inr at approximately 10:00 am was unreadable, "in excess of 26".The treatment received while the patient was admitted to the hospital was requested, but not provided.The patient had been inadvertently taking 500% of his regular warfarin dose since the (b)(6).The patient's regular dosage was requested, but not provided.The patient's therapeutic range is 2.0-3.0 inr.This mdr is being submitted in 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
• 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: 12062888
• MDR Text Key: 268342714
• Report Number: 1823260-2021-01822
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04625315172
• Device Lot Number: 48628711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2021
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR