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

Catalog Number 03666794001

Device Problems Circuit Failure (1089); Off-Label Use (1494); Device Handling Problem (3265)

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

Event Date 06/14/2023

Event Type  malfunction  

Event Description

We received an allegation of a software issue on a coaguchek xs meter.On (b)(6) 2023 the patient alleged that she was able to successfully test on the meter with a date set in the future.The meter's date was set to (b)(6) 2024.Upon inserting a new test strip with an expiration date of (b)(6) 2024, error 3 appeared.Error 3 indicates the test strip is expired.The patient alleged that "last week" she used the same vial of test strips and received a result.The meter memory was checked and the patient confirmed that on (b)(6) 2023 at 8:07 a.M.She received a meter result of 4.2 inr.

Manufacturer Narrative

Occupation is patient/consumer.The patient stated that she had not recently changed the date in the meter settings and that there were no scratches on the gold foil.The test strip lot number was 65031521 with an expiration date of 31-mar-2024.The meter was requested for investigation.

Manufacturer Narrative

The reporter¿s meter was provided for investigation where it was tested using retention strips and retention controls.The returned meter was set to the correct time/date prior to qc testing.Testing results (qc range = 2.2 - 3.4 inr): qc 1: 3.0 inr qc 2: 3.0 inr qc 3: 2.9 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 analysis of the meter error log determined there were no results acquired when the meter was set to the incorrect date.The customer received the error 3 message as intended.Error 3 indicated the test strips are expired which would be the expected meter behavior if the date was set incorrectly into the future.The investigation did not identify a product problem and revealed that the returned meter performed according to specifications.

Manufacturer Narrative

Device codes (a codes) were updated.The customer did not return the meter for investigation.According to the provided data, no information was given which would indicate a technical issue of the customer's coaguchek meter.To set the meter to the current date and time is a precondition of the meter setting.Otherwise error 3 can be triggered because it´s likely that the test strip lot is already expired by the set date to the future.The measured values have to be saved in the meter memory according to date and time.Setting the meter to a future date is technically possible, but does not correspond to the proper or prescribed setting.This is clearly explained in the coaguchek user´s manual.The investigation did not identify a product problem.

• 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: 17301901
• MDR Text Key: 319478712
• Report Number: 1823260-2023-02216
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• 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,Followup
• Report Date: 09/07/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 07/18/2023; 08/21/2023
• Supplement Dates FDA Received: 07/25/2023; 09/07/2023
• 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
• Treatment: WARFARIN.
• Patient Sex: Female