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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problems Headache (1880); Chills (2191); Dizziness (2194); Numbness (2415); Cognitive Changes (2551)

Event Date 07/16/2021

Event Type  Injury  

Manufacturer Narrative

Occupation is lay user/patient.The test strips and meter were returned for an investigation.The patient's meter was replaced.The customer had the date and time of measure set incorrectly and the investigation confirmed that the returned test strips, lot 35350321, had expired on 30-apr-2020.Per product labeling, "the test strips can be used up until the expiration date printed on the box and test strip container.Throw the test strips away if they are past the expiration date." the returned meter failed to power on with new retention batteries.The investigation performed a visual inspection of the meter's battery compartment and the battery contacts were corroded.No further testing was able to be performed on the returned meter.The customer reported that the meter flashed date and set repeatedly.This occurs to prompt the user to set the date and time when the meter has lost power.This can be caused by low batteries or corrosion in the battery compartment that interrupts the flow of power to the battery contacts.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing.For lot 35350321, with an expiration of 30-apr-2020, all retention testing passed and the last retention testing for this lot was performed on 04-jun-2020.Roche has communicated to all impacted customers instructions on how to confirm results are displayed in the measuring unit inr and the steps to take to change the measuring units back to inr if the meter is displaying the units sec or %q.Product labeling has already been updated with this information.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

We received an allegation that inr results derived from a patient's coaguchek xs meter (serial number (b)(4)) that was used in conjunction with expired test strips may have led to a stroke in the patient.On (b)(6) 2021, the initial reporter called alleging that the meter was flashing date and set repeatedly.It was determined on the call that the patient's meter's date, time, and units of measure (%q) were set incorrectly.It was reported that the patient's therapeutic range is 2.8-3.5 inr and that he tests weekly.On (b)(6) 2021, the patient's meter result was reportedly 3.2 inr.This result was not found in the patient's meter memory.There were no changes to his coumadin dosage.On the morning of (b)(6) 2021, the patient allegedly became dizzy, his eyes couldn¿t focus, and the left side of his body (lips, hand, and leg) became numb.Later that same day, the patient had chills, dizziness, and reportedly felt like he was going to pass out.The patient confirmed he had a total of four episodes and called 911.When the ambulance arrived, the patient reportedly stated he felt fine.The emergency medical technicians (emts) performed an ekg and believed the patient's cholesterol was high.The patient was not taken to the hospital and was recommended to see his doctor on (b)(6) 2021.After the emts left, the patient had two more episodes and went to the emergency room.The patient was treated with cholesterol medication, lovenox, and his coumadin dosage was increased and he was put on a heart monitor.The patient had the following diagnostic tests performed: two cat scans, one mri without dye, one mri with dye, and a carotid arteries examination.The carotid arteries examination reportedly found "a little plaque build-up on the right side but not enough for surgery." on (b)(6) 2021, the patient's inr was not tested.On (b)(6) 2021, the patient's laboratory inr result with an unknown methodology was reportedly 1.3 inr.On (b)(6) 2021, the patient was discharged from the hospital.It was reported that the patient is currently taking lovenox, his warfarin was increased, and he is currently feeling fine.

• 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: 12316501
• MDR Text Key: 266362081
• Report Number: 1823260-2021-02361
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/12/2021

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: 04/30/2020
• Device Catalogue Number: 04625374160
• Device Lot Number: 35350321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/12/2021
• 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
• Removal/Correction Number: RES 86951
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 98