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

Catalog Number 03666794001

Device Problem Off-Label Use (1494)

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

Event Date 12/03/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation is patient/consumer.The meter was requested for investigation.Replacement product was sent.

Event Description

There was an allegation of a meter issue from a coaguchek xs meter.The patient alleged that they received a 6.1 inr result using expired strips on (b)(6) 2022.They stated that they did not receive an error 3 message when they ran the test and obtained the result.Product labeling states that error 3 indicates, "the test strip has 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, turn 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." the strip lot used was 52818122 and the expiration date was 31-jul-2022.

Manufacturer Narrative

Sections d9 and h3 were updated.The meter was provided for investigation.The investigation determined that the customer was not using expired strips when they received the result of 6.1 inr.The allegation in this case could not be substantiated.After data analysis, it is determined that the returned meter meets specification.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: 16066970
• MDR Text Key: 307634240
• Report Number: 1823260-2022-04226
• 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,Followup
• Report Date: 02/15/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 02/15/2023
• 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