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 Coagulation Disorder (1779); Ischemia (1942); Paresis (1998)

Event Date 10/10/2018

Event Type  Injury  

Manufacturer Narrative

The reporter's product was requested for investigation.The complained test strips have been calibrated against the who standard and are in scope of the roche initiated recall.For these test strips there is a potential for a product problem when the inr is > 4.5.Values > 4.5 inr showed an increasing positive bias.The information in the case is consistent with the details of the recall and the issue has been fully investigated.Roche first received notice of this complaint from patient¿s daughter on 15-dec-2018.Roche determined the complaint was not reportable based on information available to roche at that time.On 31-aug-2020, roche received notice of a lawsuit filed by patient making additional allegations.

Event Description

The initial reporter stated that the patient suffered a massive stroke with related symptoms and injuries associated to use of coaguchek xs meter serial number (b)(4).On (b)(6) 2018 at 8:12 p.M., a sample from the patient was tested using the meter, resulting with a value of 3.6 inr.On (b)(6) 2018, a sample from the patient was tested using the meter, resulting with a value of 2.5 inr.On (b)(6) 2018, the patient was dropped of at his church by his wife to perform some minor repair work as a volunteer at approximately 12:30 p.M.And was last seen in his normal condition by a fellow parishioner at approximately 2:30 p.M.The patient was feeling dizzy and sat down at church.The patient's wife picked him up a few minutes after 2:30 p.M.And noted the patient had a facial droop and could not speak clearly.The patient was transported to the nearest emergency room.Upon the patient's admission to the emergency room, the patient's inr was tested in the laboratory using an unknown method, resulting with a value of 1.3 inr.The value was below the patient's therapeutic range of 2.0 - 2.5 inr and below his panic value of 1.6 inr.The patient was evaluated in the emergency room and following this evaluation, the patient was administered "tpa" and transferred for further care.The patient did not require surgery.The patient's doctor stated that the patient suffered an embolic stroke in the setting of sub-therapeutic inr.The patient's doctor stated that the stroke was caused by the patient's coumadin level being too low.The patient was in the intensive care unit for 8 days and discharged on (b)(6) 2018.The patient was in a rehabilitation facility starting on (b)(6) 2018.The patient suffered a massive stroke and related symptoms and injuries including but not limited to: acute embolisischemic cerebral infarcts (strokes) in setting of sub-therapeutic inr requiring emergent administration of "tpa".Significant cognitive deficits.Expressive and receptive aphasia.Inability to communicate.The patient received speech therapy.Severe right hemiparesis / weakness.Difficulty ambulating.Difficulty using his right arm.Dysphagia / difficulty swallowing, requiring the placement of a gastrostomy tube.Difficulty with activities of daily living.

Manufacturer Narrative

Corresponding retention test strips (lot 294151) were tested in comparison to masterlot #28632180 (recalibrated lot to rtf/09).The corresponding retention material complies with the specification.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10589982
• MDR Text Key: 208763039
• Report Number: 1823260-2020-02365
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

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: 07/31/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 29415123
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES Z-0360-2019
• Patient Sequence Number: 1
• Treatment: BLOOD PRESSURE MONITOR; WARFARIN/COUMADIN
• Patient Outcome(s): Disability
• Patient Age: 77 YR
• Patient Weight: 91