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

Catalog Number	03666794001
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The meter was requested for investigation and a new meter was sent to the customer as a replacement.Section e3 - occupation: patient/consumer.
Event or Problem Description
We received an allegation of a display issue with a coaguchek meter.The reporter stated that the meter memory and segments were faded.The reporter replaced the batteries and stated that he could barely see the numbers in the top right.During the call, a display check was performed and the reporter stated that at first he could see everything but the segments and three 8's in the middle began to fade.The meter memory was also checked.The reporter stated that he can see the "mem" on the left and the "0" on the right but the three dashes in the middle were faded.The reporter stated that there was no corrosion in the battery compartment.
Additional Manufacturer Narrative
Medwatch fields d9 device available for evaluation, d9 date device returned and h3 device not returned to mfg for eval updated.The meter was received for investigation.The investigation performed a display test; individual segments were shown faintly on the display.The investigation tested the printed circuit board (pcb) for damage and contamination; the battery contacts and pcb were contaminated by a leaked battery.The investigation determined the event was caused by contamination of the contacts due to improper handling or maintenance.Product labeling states: "- if you store the meter for a period of time, remove the batteries.-use the meter at a relative humidity of less than 85%, without condensation." "please follow the procedures below to clean and disinfect the meter.Failure to follow these procedures may cause malfunction of the meter.¿ do not use sprays of any sort.¿ ensure that swab or cloth is only damp, not wet." "wipe away residual moisture and fluids after cleaning the housing.".

• Brand Name: COAGUCHEK ® XS SYSTEM
• Common Device Name: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18028327
• Report Number: 1823260-2023-03452
• Device Sequence Number: 20573372
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K062925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown