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 05/18/2023

Event Type  malfunction  

Manufacturer Narrative

Section e3: occupation is patient/consumer.The meter has been requested for return.The investigation is ongoing.H3 other text : na.

Event Description

The customer complained of a display issue with coaguchek xs meter serial number (b)(6).Customer stated they received an error 8 and then saw either a 2 or a 3 on the meter display before the display went blank.No other display issues were noted when a meter display check was performed.There was no misinterpretation of results reported.

Manufacturer Narrative

The customer's meter and strips were returned for investigation.Observed that the returned meter powered on with fresh retention batteries.A full display check was performed and revealed no missing or faded segments.No meter display issues were observed.The returned meter and strips were tested with retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 2.9 inr qc 2: 2.9 inr qc 3: 3.0 inr the obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.Error 4 was observed in the meters error result memory.This error can be caused by test strips that are humid, the sample being applied before the 3-minute countdown starts or when the meter gets wet because it was cleaned with too much fluid.Error 8 was observed in the meters error result memory.This error can be caused when the target temperature is not reached by the heater plate when the remaining power level of the batteries are too low to finalize the measurement.The customer's allegation could not be reproduced.The returned meter and strips 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: 17113514
• MDR Text Key: 317826575
• Report Number: 1823260-2023-01945
• 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: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• 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
• Date Manufacturer Received: 06/29/2023
• 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