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

Catalog Number	04837975001
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer replaced the batteries, but the problem was not solved.No moisture, debris or corrosion was observed by the customer in the battery compartment.The meter reportedly did not appear physically damaged and the strip guide was clean.The meter was requested for investigation.
Event or Problem Description
We received an allegation of a display issue with a coaguchek xs meter.The reporter stated the meter would continually reset or give an error.When the meter did display a result, the result could not be read because the screen only partially lights up.Upon completion of a display check, the reporter saw 666 instead of 888.The meter memory was reviewed and the reporter saw what looked to be 45.5 sec but was unable to see the date.No results were misinterpreted due to the display issue.
Additional Manufacturer Narrative
The customer's meter was received for investigation.The meter¿s circuit board was tested for damage or contamination and it was found the circuit board was contaminated.The root cause is determined to be contamination of the contacts due to improper handling or maintenance by the customer.This can cause both the power and display issue.Medwatch fields d9 and h3 were updated.

• Brand Name: COAGUCHEK XS PROF KIT
• Common Device Name: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12312889
• Report Number: 1823260-2021-02346
• Device Sequence Number: 4585812
• Product Code: GJS
• UDI-Device Identifier: 00365702126107
• UDI-Public: 00365702126107
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 04837975001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1