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

Model Number XS PST

Device Problems Image Display Error/Artifact (1304); Device Difficult to Setup or Prepare (1487)

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

Event Date 11/16/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: occupation is patient/consumer (customer's son reported the issue).The meter was requested for investigation.The investigation is ongoing.

Event Description

The customer complained of a display issue with coaguchek xs meter serial number (b)(4).Customer states the meter displays a result of 0 with no result units.The display check confirmed three eights were displayed in the results field as expected.No misinterpretation of results was reported.

Manufacturer Narrative

The customer's meter was returned for investigation.It was observed that the meter powered on with fresh retention batteries.A full display check was performed and revealed no missing or faded segments.No display issues were observed.The customer's returned meter was tested using retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 4.9 inr qc 2: 4.9 inr qc 3: 5.0 inr the obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The customer's allegation could not be reproduced.The returned meter performed according to specifications.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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15951188
• MDR Text Key: 305555659
• Report Number: 1823260-2022-03952
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• 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: 12/29/2022

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: 04837738001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 12/29/2022
• 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
• Patient Sex: Female