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

Catalog Number 03666794001

Device Problems Failure to Power Up (1476); Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/14/2022

Event Type  malfunction  

Event Description

There was a complaint of a corroded battery compartment and a burn mark in the display from one patient tested with a coaguchek xs meter.The patient originally experienced a power issue and could not power on the meter.The patient washed the battery cover, cleaned the compartment contacts, and discarded the original batteries due to leaked battery acid.After exchanging the original batteries with new ones and the mentioned maintenance, the patient was able to power on the meter and complete a display test.There is a defect or burn mark in the display of the meter.The patient's therapeutic range is unknown.

Manufacturer Narrative

Occupation is a patient/consumer.The patient was using the original packaged (b)(4) oem batteries that expire in november 2024.The patient received the meter and installed the batteries on (b)(6) 2021.The meter was requested for investigation.The investigation is ongoing.

Manufacturer Narrative

The meter was received for investigation.The device could not be turned on.A visual examination was performed.The batteries used by the user were not returned.The duracell oem batteries sent along were used.There was heavy soiling noted from leaking batteries in the battery compartment.The battery contacts were also affected.The device cannot be powered on even with a direct power supply so further device information cannot be obtained.The battery supplier conducted further investigations.The battery supplier ruled out a product problem as their products undergo a 100% electrical testing before shipment to customers and defective cells would typically be detected and sorted.The issue likely occurred post-manufacturing during handling of the cells at the customer¿s site or during transportation.Medwatch fields d9 and h3 were 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13450717
• MDR Text Key: 291944014
• Report Number: 1823260-2022-00290
• 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: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• 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: 03/16/2022
• 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