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

Model Number XS PST

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

Patient Problems Speech Disorder (4415); Hemorrhagic Stroke (4417); Insufficient Information (4580)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

The meter was requested for investigation.The customer returned the meter and the strips.They were tested using a retention meter and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.2 inr, qc 2: 5.4 inr, and qc 3: 5.9 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.Error 5 was saved on the meter's log on (b)(6) 2022 and (b)(6) 2022.Product labeling states: "error: blood application - error applying blood to the test strip.Solution: turn the meter off and remove the test strip.Repeat the test using a new test strip and blood taken from a new fingerstick from a different finger." on a regular basis, coaguchek strips of all lots currently valid in the market are tested in comparison to the current master lot at roche mannheim.For this purpose, the strips are measured with two human blood samples from marcumar donors and one high-level control sample on internal reference meters.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

While troubleshooting an "error 5" message on the coaguchek meter the reporter mentioned that 2 years ago, he was allegedly unable to test on his meter due to an error and allegedly had a brain bleed a few days later.The exact date was unknown by the reporter.Based on this information the date of the event is an estimate.The reporter could not recall the error message he received 2 years ago.After a few days of not being able to test, the reporter stated that he went to the emergency room "due to a brain bleed".His inr result at the hospital from an unspecified source was reported to be 12.5.He stated that he did not receive any medical treatment while at the hospital and was sent home.The next day, the reporter stated that he was found to be in a coma at home and was care flighted to the hospital.He stated that he did not receive any medical treatment and was sent home.He further stated that he permanently has brain and speech damage due to the brain bleed.The patient's therapeutic range was reported to be 2.5-3.0 inr and testing is performed weekly.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

The error code memory log started on (b)(6) 2020 and the date of the event is (b)(6) 2020.The investigation is unable to comment further on errors obtained on or before the date of the event.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• 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: 14252873
• MDR Text Key: 291292055
• Report Number: 1823260-2022-01224
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• 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,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: XS PST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2022
• 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
• Treatment: ALLOPURINOL; AMLODIPINE; ASPIRIN; ATORVASTATIN; CENTRUM WOMEN'S MULTIVIT K 50 MCG 42% DAILY INTAKE; CINNAMON; FISH OIL; FUROSEMIDE; LISINOPRIL; LORATIDINE; METOPROLOL; MULTAQ; OMEPRAZOLE; VITAMIN C; WARFARIN
• Patient Outcome(s): Disability; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 95 KG