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

Catalog Number 07762798016

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Thromboembolism (2654); Ischemia Stroke (4418); Insufficient Information (4580)

Event Date 11/09/2022

Event Type  Injury  

Event Description

It was alleged that a patient suffered a stroke when using coaguchek inrange meter serial number (b)(4).The patient's therapeutic range is reported to be 3 - 3.5 inr.The patient allegedly measured a meter value of 3.5 inr on (b)(6) 2022.The patient was reportedly hospitalized on (b)(6) 2022 due to a stroke.In the hospital, the patient was reported to have magnetic resonance imaging (mri) and electrocardiogram (ekg) testing.The mri reportedly revealed thrombosis on the brain.It was reported that laboratory testing (unknown method) performed on the patient the next day resulted in a value of 2.4 inr.The patient reportedly had speech problems and is doing well again.The patient has reportedly been back home since (b)(6) 2022.The following information was requested, but not provided: medical history of the patient.Meter measurements performed prior to the event on (b)(6) 2022.Information on anticoagulant treatment dosage and changes in dosage.Treatment provided to the patient at the hospital.Laboratory inr upon admission of the patient to the hospital and release from the hospital.Meter values subsequent to the patient being released from the hospital.Information on clinical evaluation of the patient's mitral valve.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

The customer's meter and test strips were requested for investigation.The test strips have not been received at this time.If the product is returned in the future, a follow-up report will be submitted.The customer's meter was returned for investigation where it was tested using retention test strips and retention controls.Testing results (qc range = 2.4 - 3.0 inr): qc measurement 1 = 2.7 inr; qc measurement 2 = 2.7 inr; qc measurement 3 = 2.7 inr.All inr values were within the specified target ranges, confirming the functionality of the complained coaguchek meter.No error messages occurred.Upon review of the meter's patient result memory, it was observed that no values were measured on (b)(6) 2022.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.The initial reporter was reported to be the patient's husband.The occupation is patient/consumer.

• Brand Name: COAGUCHEK XS PT TEST PST
• 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: 15995598
• MDR Text Key: 305599007
• Report Number: 1823260-2022-04040
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2022

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: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 07762798016
• Device Lot Number: 62681812
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/16/2022
• 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
• Patient Outcome(s): Hospitalization
• Patient Sex: Female