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

Catalog Number 03666794001

Device Problems Device Difficult to Setup or Prepare (1487); Incorrect, Inadequate or Imprecise Result or Readings (1535); Lack of Maintenance Documentation or Guidelines (2971)

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

Event Date 06/23/2023

Event Type  malfunction  

Manufacturer Narrative

Section e3: occupation is patient/consumer.The test strip lot number was 63658921 with an expiration date of 31-mar-2024.The meter and test strips were requested for investigation.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.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 meter was set to the incorrect unit of measure (%q).Product labeling states: "the coaguchek xs meter is pre-set to display results in the international normalized ratio (inr).The meter is also capable of displaying results in seconds (displayed on meter as sec) and % quick (displayed on meter as %q) (a measuring unit used mainly by healthcare professionals in europe).When testing for inr, you must confirm that the measured result is displayed in inr prior to using the result and whenever the date and time settings are modified.".

Event Description

There was an allegation of discrepant %q results on a coaguchek xs meter.The result at 10:23 a.M.Was 9 %q.The result at 10:25 a.M.Was 12 %q.The result at 10:39 a.M.Was 11 %q.The patient reported this result at 1.1 inr.The patient¿s warfarin was increased by ½ pill.The patient was not harmed by this adjustment.The patient used the same finger for one of these tests but could not remember which test.Product labeling states: "if you need to redo a test, use a new lancet, a new test strip, and a different finger." the patient¿s therapeutic range is 2 ¿ 3 inr.The patient normally tests every 2 weeks.

Manufacturer Narrative

The meter was received for investigation.The meter was tested using retention strips and retention controls.Level 1 testing results (qc range = 1.0 - 1.4 inr): qc 1: 1.2 inr level 2 testing results (qc range = 2.3 - 3.5 inr): qc 2: 2.8 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 returned material and the retention material meet the specification.The alleged results were observed in the meter¿s patient result memory.The patient had incorrectly set the meter to the units of %q and thereby misinterpreted the results by inserting a decimal point.The investigation determined the event occurred due to operator error.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: 17346642
• MDR Text Key: 319420678
• Report Number: 1823260-2023-02341
• 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: 07/23/2023

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: 06/26/2023
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 07/24/2023
• 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
• Treatment: ALBUTEROL; ATORVASTATIN; BUDESONIDE; BUPROPION; CARVEDILOL; CHONDROITIN GLUCOSAMINE; CLARITIN; DIMEPROZIL; DOCUSATE; FAMOTIDINE; FLONASE; KRILL OIL; LASIX; LOSARTAN; MAGNESIUM OXIDE; MULTIVITAMIN WITH VITAMIN K; OMEPRAZOLE; POTASSIUM FLUORIDE; SPIRONOLACTONE; TAMSULOSIN; VITAMIN D3; WARFARIN
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 73 KG