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 Stroke/CVA (1770); Insufficient Information (4580)

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

No product is expected for return since the customer has returned the meter to the diagnostic testing facility and the test strips are no longer available.If any 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 results have passed the internal inspection. per product labeling: "coaguchek method uses human recombinant thromboplastin.Therefore, the comparability to tests using other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastin types.However, those higher differences between thromboplastins of different (rabbit, bovine) origin are not an issue specific for coaguchek assays.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared with several other (rabbit, bovine) laboratory methods." occupation is patient/consumer - the reporter is the patient's husband.

Event Description

The reporter initially called because he and his wife (the patient) received phone calls from an independent diagnostic testing facility regarding the patient's inr tests.During the call, the reporter mentioned two stroke events allegedly occurring while the coaguchek xs system was in use.Stroke event 1: on or about (b)(6) 2022, the patient reportedly had her first stroke.The reporter stated that he could not recall the meter results related to this event.Stroke event 2: on or about (b)(6) 2022, the patient reportedly began to recover from the first stroke when she had another stroke.The reporter stated that the patient had to be transported to the hospital.He also stated that when he looked at the patient, she was trying to wave him over and then was unresponsive when he got to her across the room.The reporter stated it was determined that the patient had a stroke at the hospital.The reporter stated that he thinks that the last laboratory result at the hospital on (b)(6) 2022 was 1.1 inr and then they released her to the nursing home on eliquis instead of warfarin.The serial number of the meter was unknown.The reporter stated that they already returned the meter to the independent diagnostic testing facility as the patient was reportedly switched to the medication eliquis after the second stroke.The reporter stated that the meter worked fine but they always had a hard time keeping the patient's inr within the therapeutic range because of the changes in the patient's antibiotic intake and other health issues she had.The patient's therapeutic range was reported to be 2.0-3.0 inr.Additional information was requested, but could not be obtained despite multiple follow up attempts.This information includes: patient's indication for anticoagulation; type of strokes; treatment related to the strokes; any warfarin changes.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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 14938234
• MDR Text Key: 295404958
• Report Number: 1823260-2022-01977
• 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: 07/06/2022

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 Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 07/06/2022
• 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: ELIQUIS; WARFARIN
• Patient Outcome(s): Other
• Patient Sex: Female