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

Catalog Number 03666794001

Device Problems Circuit Failure (1089); Display Difficult to Read (1181)

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

Event Date 10/15/2021

Event Type  malfunction  

Manufacturer Narrative

The meter was requested for investigation.Replacement product was sent.The investigation is ongoing.Initial reporter occupation is patient/consumer.

Event Description

There was an allegation of a display issue with a coaguchek xs meter.The reporter stated the three 8's were visible on the full display and the result from last week was able to be read.However, the segments on the meter's display were faint.The reporter confirmed the meter's heater plate and battery compartment were clean.

Manufacturer Narrative

The patient's meter was returned for investigation.The device data and fault memory were read.A display test was performed.The circuit board was tested for damage or contamination.The investigation found the display did not show any noticeable contrast errors.The investigation discovered the battery compartment was contaminated by a leaked battery and the circuit board was contaminated by penetrated liquid, which affected the conductive rubber contacts.To ensure that the coaguchek xs meter functions correctly, product labeling states "use the meter at a relative humidity of less than 85%, without condensation." also, "if you store the meter for a period of time, remove the batteries." for cleaning/disinfecting the meter, product labeling states "it is important to follow the procedures below to clean and disinfect the meter.Failure to follow these procedures may cause malfunction of the meter.Do not use sprays of any sort.Ensure that swab or cloth is only damp, not wet." also, "wipe away residual moisture and fluids after cleaning the housing." the investigation determined the event was consistent with a user error.Updated medwatch fields: d9 and h3.

• 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: 12771348
• MDR Text Key: 280484195
• Report Number: 1823260-2021-03250
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• 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: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2021
• 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