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

Catalog Number 03666794001

Device Problem Circuit Failure (1089)

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

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation is lay user/patient.Unique device identifier (udi) (b)(4).For error 3, product labeling states "test strip expired.Solution: check the meter¿s date setting.If it is not correct, set the correct date.For more information, see the meter setup section of this manual.If the date is correct, power the meter off and remove the code chip and the test strip.Then use the code chip and a test strip from a new box of test strips." for error 6, product labeling states "test strip interference.Solution: power the meter off and remove the test strip.Repeat the test using a new test strip and blood taken from a new fingerstick from a different finger.Do not touch or remove the test strip when a test is in progress." the patient's meter was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 2.2 - 3.4 inr): qc 1: 3.1 inr.Qc 2: 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.The meter's error memory was downloaded and reviewed.Error 3 (349) was observed on (b)(6) 2021 at 9:24 am and then again at 9:24 am.Error 6 (662) was observed on (b)(6) 2021 at 9:45 am and error 6 (624) was observed on (b)(6) 2021 at 9:51 am.The alleged malfunction was not reproducible.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

There was an allegation that the coaguchek xs meter reached the countdown stage for testing when expired test strips were used and the corresponding error message, error 3, did not populate.The test strips were lot 43492523 with an expiration date of 30-apr-2021.The date on the meter was set to (b)(6) 2021 in the format of 31-12-00.The patient updated the format of the date to 12-31-00 and the date displayed on the meter was (b)(6) 2021, which was determined correct.The patient attempted to perform a test with the expired test strips and the patient was able to reach the countdown stage.The patient's blood was applied to the test strip and an error 3 was received.The patient attempted to perform a test with the expired test strips again.The patient reached the countdown stage and applied the blood to the test strip, but received an error 6.The patient confirmed no results were received with the expired test strips.The patient switched to a non-expired lot of test strips and a matching code chip.The patient performed a test with no issues and received a result.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 11932766
• MDR Text Key: 270674326
• Report Number: 1823260-2021-01650
• Device Sequence Number: 1
• Product Code: GJS
• 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
• Report Date: 06/03/2021

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 06/03/2021
• 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