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

Catalog Number 04625374160

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Coagulation Disorder (1779)

Event Date 07/24/2023

Event Type  Injury  

Manufacturer Narrative

Section e3: occupation is hospital case manager.Note: additional event details were provided by the patient's son.The coaguchek xs meter serial number was (b)(6).The meter and test strips were requested for investigation, however, the strips have been discarded.No product has been received at this time.If any 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.For the results in sec, 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

We received an allegation that a patient was reportedly hospitalized due to high inr levels.It was alleged that the patient¿s coaguchek xs meter was "broken." the patient was reportedly admitted to the hospital on (b)(6) 2023 at 3:00 a.M.The patient¿s result from an unknown laboratory method upon admission was reportedly 6.3 inr.The patient¿s warfarin dose was reportedly held.The patient allegedly had visible bruises prior to going to the hospital.The patient would reportedly scratch his arms and legs and would cut himself unintentionally and "gush" blood.The patient was taken to the hospital due to bruising and the cuts that were bleeding.The patient reportedly also had signs of bleeding around his toenails.The reporter did not know what treatment was received in the hospital but believes the patient "probably" received vitamin k treatment due to the 6.3 inr result from the laboratory.Prior to the hospitalization, it was alleged the meter "not working" and the patient was unable to obtain a result on the meter.It was determined the patient¿s meter was set to an incorrect unit of measure.The meter was set to read in seconds (sec) unit of measure instead of inr.The call agent assisted in resetting the meter to the correct unit of measure.The reporter believes the patient last attempted to use the meter on (b)(6) 2023 and a result in sec was obtained but the patient did not understand the meter was displaying a result in a different unit of measure and thought the meter was "not working." on (b)(6)2023 the result at 3:55 p.M.Was reportedly 57.1 sec (4.8 inr).The patient reportedly refused to go to the clinic for testing by another method.The last result the patient reported was obtained on (b)(6) 2023.The meter memory was reviewed on the call and the result on (b)(6) 2023 at 12:27 p.M.Was allegedly 28.2 sec.The reporter does not know whether the patient reported the result in sec or inr.The patient¿s warfarin dose was reportedly increased based on the result reported on (b)(6) 2023.The patient¿s warfarin dose was reportedly increased to 4 mg warfarin 3 days per week and 2 mg warfarin the other 4 days.The patient¿s normal warfarin dose was not known by the reporter.The patient reportedly maintained this increased dosage until the hospitalization on (b)(6) 2023.The patient¿s therapeutic range is reportedly 2.5 ¿ 3.5 inr with an alleged testing frequency of weekly.The patient is currently in the hospital reportedly awaiting a blood transfusion.This mdr is being submitted in an abundance of caution.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17615331
• MDR Text Key: 321872599
• Report Number: 1823260-2023-02764
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/24/2023
• 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: ASPIRIN; WARFARIN
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 72 KG