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

Catalog Number 03666794001

Device Problems No Device Output (1435); Device Difficult to Setup or Prepare (1487); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 07/28/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: occupation is hospital case manager.The meter and strips were requested for investigation.A replacement meter was sent.The meter was provided for investigation where it was tested using retention strips and controls.Testing results (qc range = 4.1- 6.8 inr): qc 1: 5.1 inr, qc 2: 5.2 inr, qc 3: 5.1 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and the results have passed the internal inspection.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

On 22-jul-2022 we received a call complaining of an issue running a test with coaguchek xs meter serial number (b)(4).The patient attempted to test and received an error 5.This is an error related to applying the blood to the test strip.The back of the test strip was checked and the blood sample was too small.The blood sample size was reviewed and the patient attempted another test and received an error 6.This error is related to touching or removing the test strip during the test.The patient continued to have an issue obtaining a large enough blood sample for a successful test.On 29-jul-2022 we received information that the patient was reportedly in the hospital.On (b)(6) 2022 the patient reportedly arrived at the hospital and was admitted due to blood in her urine and bruising at her extremities.Her inr from the hospital upon arrival was reportedly > 9.0 inr.The patient was treated with an unspecified dosage of vitamin k to lower her inr.The patient's inr had allegedly continued to be > 9.0 inr since (b)(6) 2022 while in the hospital.The patient was last tested at 5:00 a.M.On (b)(6) 2022 in the hospital and the result was reportedly > 9.0 inr.The patient reportedly did not know when she last took coumadin due to having trouble testing with the meter.It is not known how long the patient had not been able to test on the meter.The patient's therapeutic range is reportedly 2.0 - 3.0 inr with an alleged testing frequency of weekly.Additional information was requested related to other diagnostic testing or other treatment the patient may have received in the hospital, however, this was not provided.

Manufacturer Narrative

In relation to error messages from the device, product labeling states: "you may see the following error messages while using the coaguchek xs meter.If you see an error message, first try to correct the problem using the solution described below.If the problem persists, call roche customer support center." the patient was reportedly discharged from the hospital "an estimated 2 weeks ago" (approximately (b)(6) 2022).The patient was not sure of the specific date.The patient is currently in "normal condition;" she just stated she reportedly felt "down.".

• 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: 15306796
• MDR Text Key: 298775833
• Report Number: 1823260-2022-02603
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• 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: COUMADIN
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female