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 12/09/2021

Event Type  malfunction  

Event Description

There was an allegation of an error 5 and missing meter results with a coaguchek xs meter.It was reported an error 5 was received and the previous 6 weeks of inr results were all 3.0 inr.The reporter stated the time and date in the meter were correct.The meter's memory was checked and it had the following results: on (b)(6) 2021, the patient's meter result was 3.0 inr.On (b)(6) 2021, the patient's meter result was 2.7 inr.On (b)(6) 2021, the patient's meter result was 2.2 inr.On (b)(6) 2021, the patient's meter result was 2.1 inr.The patient's therapeutic range was 2.0-3.0 inr.The patient's testing frequency is weekly.

Manufacturer Narrative

For error 5, product labeling states "error: blood application error applying blood to the test strip.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." the meter was requested for investigation.Replacement product was sent.The investigation is ongoing.Occupation is patient/consumer.

Manufacturer Narrative

The meter was not returned for an investigation.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 13593577
• MDR Text Key: 292718447
• Report Number: 1823260-2022-00504
• 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
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• 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
• Date Manufacturer Received: 03/16/2022
• 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
• Treatment: WARFARIN
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 59 KG