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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problems Visual Impairment (2138); Dizziness (2194); Balance Problems (4401); Speech Disorder (4415); Ischemia Stroke (4418)

Event Date 08/28/2021

Event Type  Injury  

Manufacturer Narrative

The meter was provided for investigation.Upon investigation, the returned meter failed to power on with fresh retention batteries.Examination of the battery compartment revealed heavy contamination due to a leaked battery.The contamination prevents the meter from powering on.The meter cannot be tested further.The test strips were provided for investigation where they were tested using a retention meter and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.2 inr, qc 2: 5.0 inr, qc 3: 5.2 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.Occupation was patient/consumer.The initial reporter was the patient's husband.

Event Description

There was an allegation of questionable results from coaguchek xs meter serial number (b)(4) and an allegation the patient had a cerebral stroke due to blood clots generated by a st jude valve because the patient's inr was low.On (b)(6) 2021, the patient had double vision and felt dizzy so she was driven to the hospital.Testing on the meter was not performed prior to going to the hospital on this date.The result from the hospital laboratory using an unknown reagent was reportedly 1.0 inr.The patient was reportedly put on lovenox based on this result.A ct (computed tomography) scan was performed which reportedly showed a hemorrhage in the brain, but allegedly no bleeding was found in the brain.When asked about the ct scan findings, the reporter alleged that the doctor suspects that it was a hemorrhage but no blood was detected on the ct scan.On (b)(6) 2021, the patient had an mri and an mra that reportedly showed there were a few small clots located in the narrow lower part of the brain stem.No blood loss was seen.An ultrasound of the heart was performed and the valve evaluation was okay.The patient was hospitalized for a week and because of the stroke, the patient has double vision, tremors in the hand, balance issues, and some speech issues.The patient is reportedly continuing to improve in all areas of recovery.The therapeutic range was 2.5-3.5 inr and the patient tests weekly.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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12869155
• MDR Text Key: 281213019
• Report Number: 1823260-2021-03473
• 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: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 52333121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Date Manufacturer Received: 10/29/2021
• 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: ATORVASTATIN; CENTRUM VITAMIN COMPLEX; DULOXETINE; HUMALOG; METOPROLOL; NIFEDIPINE; RAMIPRIL; TOLTERODINE; TRULICITY; WARFARIN
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 102 KG