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

Model Number XS PST

Device Problem Circuit Failure (1089)

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

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

The customer cleaned the battery contacts but the meter would still not power on.The meter was requested for return.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.Occupation was lay user/patient.

Event Description

The customer was receiving an error 3 (the test strip has expired.) and noticed crystallization in battery compartment of the coaguchek xs meter.As the meter would then not power on, the customer opened the battery compartment and noticed a black burned area on the positive and negative side where one battery was sitting.The customer described it as a "low voltage short".

Manufacturer Narrative

The customer's meter was received for investigation.The battery contacts in the battery compartment are dirty and corroded.The contamination is interrupting the battery contacts preventing the meter from powering on.The contamination is clearly due to a leaked battery.The root cause is determined to be contamination of the battery 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
• MDR Report Key: 12189409
• MDR Text Key: 262294878
• Report Number: 1823260-2021-02085
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

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: Lay User/Patient
• Device Model Number: XS PST
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1