MAUDE Adverse Event Report: ROCHE COAGUCHEK XS; PLASMA CONTROL

Device Problem Data Problem (3196)

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

Event Date 06/24/2016

Event Type  malfunction  

Event Description

Invalid test result displayed on inr meter; invalid result status indicated only by a "c" beneath the result in a smaller font than anything else on the screen; no info on "c" flag in product literature, had to call mfr to determine meaning of flag.Fingerstick inr obtained on pt in physician office setting, staff member noted small "c" below result.No info on this found in mfr's user manual or package insert; called mfr tech support and was told the "c" meant that the result was invalid if we hadn't called, an invalid result would have been reported and acted on.This is a especially concerning as this meter is also used for home testing inrs and the "c" could easily be missed.The potential consequences of inaccurate inr test results are severe and potentially life threatening.When tech support was contacted, they said the error code is reported to them "maybe once a month".When asked for written documentation as to the meaning of this code, they at first could not find any.They later faxed a copy of a letter dated 2011 which described factors that may cause the error to occur.We obtained our meters in 2015.User manual is dated 2013, 2 years after the advisory letter was sent out, but manual was not updated to include this info.

• Brand Name: COAGUCHEK XS
• Type of Device: PLASMA CONTROL
• Manufacturer (Section D): ROCHE
• MDR Report Key: 5778274
• MDR Text Key: 49144050
• Report Number: MW5063283
• Device Sequence Number: 1
• Product Code: GJS
• 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: 07/05/2016

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1