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 Problems Transient Ischemic Attack (2109); Insufficient Information (4580)

Event Date 03/28/2022

Event Type  Injury  

Manufacturer Narrative

Occupation is patient/consumer.The meter and test strips were requested for investigation.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: 5.2 inr, qc 2: 5.2 inr, qc 3: 5.5 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 results have passed the internal inspection.It was determined that the patient pokes her finger prior to powering the meter on and the countdown.The patient was not dosing the strip within 15 seconds of their fingerstick.Product labeling states: "after sticking your finger, you have 15 seconds to apply blood to the test strip.If it takes longer to form a good drop of blood, lance a different finger for the test." the investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

We received an allegation of questionable inr results, multiple transient ischemic attacks (tias) and multiple falls while coaguchek xs meter serial number (b)(4) was in use.The date of event is an approximation; the date of events for the tias and falls were requested but were not provided.The reporter alleged the patient¿s inr has been erratic ever since the patient received her mechanical valve around 2013 or 2014.The patient allegedly began to use the coaguchek xs meter on (b)(6) 2016.The inr results from the meter related to the tias and falls were not provided as the reporter did not know exactly when these events occurred.The patient¿s warfarin dose is allegedly changed weekly based on the device results.The patient takes between 8 mg and 10 mg daily depending on the instructions given by her healthcare provider.The patient reportedly does not have good balance but it has not been determined why.The patient has reportedly had "several" diagnostic tests performed (mris, echocardiograms and bloodwork) but has not received any treatment.The results from the diagnostic testing "all came out fine." no actual results were provided.The patient has allegedly had "injuries" to her leg, ribs, knees and eyes from the falls, however, no treatment has been required.The reporter stated the tias do not show up on mris so it is not known how the doctors know the patient has had tias.The patient alleges she sometimes has trouble thinking of words and believes the tias might be why.The patient has reportedly been assigned physical therapy and a cane due to the falls.The patient¿s therapeutic range was unknown but is allegedly around 3.5 inr.The patient reportedly tests weekly.Examples of additional information requested but not provided at this time include: the event dates for the tias and falls.The meter results prior to or at the time of the events.Any meter to laboratory comparison inr results.The patient¿s therapeutic range.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

The component code was updated.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14214694
• MDR Text Key: 290155926
• Report Number: 1823260-2022-01200
• 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,Followup
• Report Date: 05/17/2022

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 Expiration Date: 11/30/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 54145321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 04/26/2022
• Supplement Dates FDA Received: 05/17/2022
• 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: AGGRENOX; ASPIRIN; CENTRUM SILVER C; FLAX SEED OIL; LAMOTRIGINE; WARFARIN; ZOLOFT
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female