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

Catalog Number 04625374160

Device Problems Circuit Failure (1089); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/28/2022

Event Type  malfunction  

Event Description

We received an allegation of discrepant inr results with coaguchek xs meter serial number (b)(4).The result at 6:42 a.M.Was 4.7 inr.The patient re-tested using the same finger at 6:45 a.M.And the result was 6.3 inr.Product labeling states "if you need to redo a test, use a new lancet, a new test strip, and a different finger." the patient re-tested using a different finger at 6:52 a.M.And the result was 6.8 inr.The patient¿s therapeutic range is 2.5 ¿ 3.5 inr with a testing frequency of weekly.

Manufacturer Narrative

Occupation is patient/consumer.The customer also stated the meter has been dropped "many times" and complained of an error 6.The meter and test strips were requested for investigation.The meter was provided for investigation where it was tested using retention strips and retention controls.The test strips were not returned.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.4 inr, qc 2: 5.4 inr, qc 3: 5.2 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 alleged results were observed in the meter¿s patient result memory.However, the meter's time and date were set incorrectly.A review of the meter's error log showed error 6.Error 6 occurs due to errors in operation by the operator, e.G.When the test strip was moved.In rare cases, a defective (scratched) test strip can trigger this error.Product labeling for error 6 states: "error: test strip interference, the test strip was touched or removed during the test." on a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.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 TEST STRIPS
• 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: 16203113
• MDR Text Key: 308158107
• Report Number: 1823260-2023-00181
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• 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: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 04625374160
• Device Lot Number: 63311221
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2022
• 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: AMITRIPTYLINE; ASPIRIN; FOLINIC; HUMALOG; INTRESTO; LEXAPRO; METOPROLOL; NORCO; PANTOPRAZOLE; POTASSIUM; ROSUVASTATIN; TOUJEO; VITAMIN D; WARFARIN
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 107 KG