MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH ROCHE COAGUCHEK XS, COAGUCHEK XS PLUS; TEST, TIME, PROTHROMBIN

Catalog Number 05021537001

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Reporting concern with roche coaguchek xs, coaguchek xs plus, and coaguchek xs pro systems and inadequate instructions for use (ifu) regarding cleaning and disinfection.Original ifus stated disinfecting with 70% isopropyl alcohol or 10% bleach solution.In february, roche issued a memo to stop using bleach and only use 70% alcohol.Alcohol alone is not sufficient to disinfect items that are contaminated with blood between patients.The coaguchek devices are very similar to blood glucose meters.My understanding is that they function very similarly, requiring blood from the patient, meaning both the inside and outside of the device can become contaminated.While the cdc has placed a large focus on blood glucose meters, it has not recognized the myriad of additional mobile laboratory equipment that can be used across multiple patients.Given considerable feedback (likely similar to mine), a new memo was published in september 2019.This memo states that users can use 10% bleach, but that after 400 bleach disinfection cycles, the monitor may not report accurate patient results.Roche must be able to provide adequate cleaning and disinfection recommendations for these devices the 70% alcohol alone will not protect patients from all bloodborne pathogens, and certainly not for multidrug resistant pathogens that are becoming more common in the community.Fda safety report id # (b)(4).

• Brand Name: ROCHE COAGUCHEK XS, COAGUCHEK XS PLUS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 9322236
• MDR Text Key: 166747727
• Report Number: MW5091082
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05021537001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other