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

Model Number XS PST

Device Problem No Device Output (1435)

Patient Problems Chest Pain (1776); Dyspnea (1816); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2021

Event Type  Injury  

Manufacturer Narrative

The batteries in the meter were replaced but this did not resolve the issue.The meter was requested for return.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.Occupation was patient/consumer.

Event Description

There was an allegation of power issues with the coaguchek xs meter where it would not turn on.Due to the power issues, the patient was not able to test for some time.Information concerning the last time the patient was able to test using the meter was requested, but it was not known.On (b)(6) 2021, the patient was having shortness of breath and chest pain.The patient had received a flu shot earlier in the day so she went to the er.The result from the hospital laboratory using an unknown reagent was reportedly 6.0 inr.The patient was admitted to the hospital and was reportedly treated with vitamin k.The patient's current condition was provided as "better".The therapeutic range and testing frequency were requested but were not provided.The serial number of the meter was requested but was not provided.Examples of additional information requested but not provided at this time include: patient age, indication for anticoagulation, therapeutic range, medical history, all medications, information related to the hospitalization, changes to anticoagulation drug dosage, infection or reported fever, diagnostics performed in the hospital, the last five inr results from the meter before the event.

Manufacturer Narrative

No product was received for investigation.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• 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: 12924990
• MDR Text Key: 281738405
• Report Number: 1823260-2021-03572
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• 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
• Report Date: 01/06/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: XS PST
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 12/27/2021
• Supplement Dates FDA Received: 01/06/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female