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

Catalog Number 03666794001

Device Problem Circuit Failure (1089)

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

Event Date 01/28/2022

Event Type  malfunction  

Event Description

There was an allegation of a corroded battery compartment and a burn mark on the battery contacts with a coagucheck xs meter.The patient originally experienced a power issue and could not power on the meter.The patient attempted to clean the battery contacts and install new batteries, but the meter would not power on.The patient noted that of the battery contacts appear blackened as though there was an electrical short or a burn.The patient's therapeutic range is unknown.

Manufacturer Narrative

Occupation is (b)(6).The patient's meter was requested to be returned for investigation.The investigation is ongoing.Na.

Manufacturer Narrative

The meter was returned for investigation.The device error memory was examined and error 142 was observed indicating the battery voltage was too low.Deposits and corrosion from leaking batteries can be seen on the battery contacts in the battery compartment.This led to increased contact resistance of the contacts and the observed error 142.No excessive heating of the device was observed.The cause of the corrosion observed in the battery compartment is due to handling error.

• 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: 13569084
• MDR Text Key: 285991403
• Report Number: 1823260-2022-00466
• 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: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• 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?: No
• Date Manufacturer Received: 03/10/2022
• 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