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

Catalog Number 04625374160

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 04/27/2022

Event Type  Injury  

Manufacturer Narrative

The meter and test strips were requested for investigation and have 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 the results have passed the internal inspection. occupation is patient/consumer.

Event Description

We received an allegation that a patient who uses the coaguchek xs meter with serial number (b)(4) fell and hit her head while in the shower or bathroom.On (b)(6) 2022, the patient initially called to ask for assistance performing a test.During the call, the patient stated that on (b)(6) 2022, she fell in the shower or bathroom and hit her head.She reportedly does not remember anything, only that she fell.Upon review of the meter results, the meter result on (b)(6) 2022 at 10:49 am was 2.7 inr.It is unclear if the patient fell because of a brain bleed or if the brain bleed was caused by the trauma.She was reportedly brought to the hospital where a computerized tomography (cat scan) reportedly showed blood clots in her upper right and left atrium.She was reportedly taken off her warfarin in the hospital and was treated with another medication.Reportedly the patient did not know any results of her bloodwork and did not know whether her inr was checked while in the hospital.She reportedly stayed in the hospital for 10 days and then in a rehabilitation facility for 3 weeks.On (b)(6) 2022, she was reportedly started on warfarin.The therapeutic range was reported to be 2.0-3.0 inr.The patient's interval of testing was reported to be every 4-5 days since restarting warfarin.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

Mdr code - component code - new component code was updated.

Manufacturer Narrative

The customer's meter was returned for investigation.It was observed that the returned meter failed to power on.An examination of the battery compartment revealed corroded battery contacts (handling error) due to leaking batteries.The power supply of the device is interrupted no further investigation can be conducted on the customer's returned meter due to the corrosion.The root cause for the meter failing to power on is the contamination of the contacts due to improper handling or maintenance.Product labeling states "if you store the meter for a period of time, remove the batteries.".

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15252889
• MDR Text Key: 298171925
• Report Number: 1823260-2022-02494
• 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,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• 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
• Date Manufacturer Received: 11/03/2022
• 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: CARVEDILOL.; FLUOXETINE 40MG.; GABAPENTIN 300MG.; IRON.; LATANOPROST EYE DROPS.; OMEPRAZOLE.; POTASSIUM 20MG.; ROPINIROLE 1MG.; SILVER CENTRUM.; SPIRONOLACTONE.; STOOL SOFTENERS.; WARFARIN.
• Patient Outcome(s): Hospitalization
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 73 KG