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

Catalog Number 03666794001

Device Problems Image Display Error/Artifact (1304); Device Sensing Problem (2917)

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

Event Date 11/02/2022

Event Type  malfunction  

Event Description

There was an allegation of a display issue with the coaguchek xs meter.After replacing the batteries, the customer alleged the display was missing segments and the "00" in date format looked like an "l7".When performing a display check, the customer stated one segment was missing from an "8" in the results.There was no allegation of a result misinterpretation.

Manufacturer Narrative

The meter was requested to be returned.The investigation is ongoing.

Manufacturer Narrative

The meter was returned for investigation.The device could not be powered on.The battery contacts and the circuit board are contaminated by liquid.The contamination effects the battery contacts on the circuit board, which are interrupted by the contamination.The root cause is determined to be contamination of the contacts due to improper handling or maintenance by the customer.Medwatch fields d9 and h3 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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15833466
• MDR Text Key: 307723178
• Report Number: 1823260-2022-03697
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2022

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: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 12/09/2022
• Supplement Dates FDA Received: 12/28/2022
• 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