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

Catalog Number 03666794001

Device Problems Incorrect Measurement (1383); Device Difficult to Setup or Prepare (1487)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

The reporter's meter was requested for investigation and replacement product was sent to the reporter.

Event Description

The initial reporter stated there was an issue with the coaguchek xs meter serial number (b)(4) as the meter displayed an incorrect unit of measure after setting the correct unit of measure.The reporter tested herself with the meter, resulting in a value of 13.2 at 12:27 a.M.The reporter stated she removed the batteries from the meter and inserted them back into the meter.The meter powered on and "set" and "date" were flashing on the display.When checking the meter memory, the 13.2 value was in units of seconds.The reporter changed the unit setting on the meter from seconds to inr.When checking the meter memory, the same 13.2 sec measurement changed to 1.1 inr.The reporter was advised to turn the meter off and to check the memory again.The meter displayed 13.2 sec after the unit setting had been changed to inr.When the reporter entered "set" mode on the meter, the meter displayed "set" and "sec".The meter unit setting was then changed back to inr.A display check was performed and the display was complete.The meter's patient result memory showed a value of 1.1 inr at 12:27 a.M.The reporter confirmed she set the units of the meter to inr, but then the meter switched back to units of seconds.

Manufacturer Narrative

The customer's meter was returned for investigation where it was tested using retention batteries, retention test strips, and retention controls.The meter powered on without difficulty with fresh retention batteries.A full display check was performed and no missing segments or display malfunctions were observed.Upon review of the meter's patient result memory, it was observed that units were set to inr.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 3.0 inr qc 2: 3.1 inr qc 3: 3.0 inr the obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The maximum difference between measurements was 3%.All obtained qc values were observed in inr units.Meter was powered off then powered back on to observe that the meter was still set to inr units.The customer accidentally set the meter units to seconds instead of inr and did not realize it.The device meets specifications.The meter is provided to u.S.Customers pre-set to the measuring unit inr.There are two additional measuring units on the meter: %quick (%q) and seconds (sec).In the u.S., the most accepted unit of measure is inr.Roche has communicated to all impacted customers instructions on how to confirm results are displayed in the measuring unit inr and the steps to take to change the measuring units back to inr if the meter is displaying the units sec or %q.Medwatch fields d9., h3., and h9.Have been updated.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12479807
• MDR Text Key: 271675596
• Report Number: 1823260-2021-02704
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

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
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Initial Date Manufacturer Received: 08/26/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 09/16/2021
• Supplement Dates FDA Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 86951
• Patient Sequence Number: 1