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

Catalog Number 04625374160

Device Problems Image Display Error/Artifact (1304); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/23/2022

Event Type  malfunction  

Event Description

There was an allegation of discrepant inr results with coaguchek xs meter serial number (b)(4).The initial result was 5.9 inr.The patient alleges the result changed from 5.9 inr to 6.9 inr.The patient powered off the meter and re-tested using a new finger and obtained a result of 3.4 inr.Based on the result of 3.4 inr, no changes were made to the patient¿s warfarin dose the patient¿s therapeutic range is 2.5 inr ¿ 4.5 inr with a testing frequency of every 2 weeks.

Manufacturer Narrative

Initial reporter occupation: occupation is patient/consumer.The meter and test strips were requested for investigation.The meter and test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 4.1 ¿ 6.8 inr): qc 1: 5.2 inr, qc 2: 5.1 inr, qc 3: 5.1 inr.The obtained qc values were in the allowed range of the used combination strip lot and qc lot.All measurements were without error messages.The results of 5.9 inr and 3.4 inr were observed in the meter¿s patient result memory with the incorrect date and time.The alleged result of 6.9 inr was not observed in the meter¿s patient result memory.No display issues were observed during the investigation.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: 15456754
• MDR Text Key: 306030845
• Report Number: 1823260-2022-02882
• 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: 09/20/2022

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: 04625374160
• Device Lot Number: 565613-22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2022
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/20/2022
• 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: COREG; ENTRESTO; FUROSEMIDE; POTASSIUM; SPIRONOLACTONE; WARFARIN
• Patient Age: 61 YR
• Patient Sex: Female