MAUDE Adverse Event Report: COAGUSENSE INC COAG-SENSE PT/INR SYSTEM; TEST, TIME, PROTHROMBIN

Lot Number 210292

Device Problems Device Markings/Labelling Problem (2911); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 03/07/2022

Event Type  malfunction  

Event Description

Reporter calling to report a product quality problem.Caller takes warfarin and as part of her routine care, monitors her inr levels weekly at home using a coag-sense pt/inr system.Caller reports that test strips shipped to her have arrived damaged and bent, and she has reached out to the equipment distributor (remote cardiac services, aka rcs) to report this problem.In addition, each package of supplies that is shipped must also contain a barcode number; this barcode number is essential as it must be manually input into her coag-sense pt/inr system in order to evaluate her blood sample.One of the packages of supplies she received was missing this barcode number, and without it she cannot operate her equipment.She has attempted communication regarding these problems with the device manufacturer, the distributor, as well as her doctor's office and feels like each entitiy is pointing the finger of blame at the other.She is frustrated and so is reporting to fda.

• Brand Name: COAG-SENSE PT/INR SYSTEM
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): COAGUSENSE INC
• MDR Report Key: 13711859
• MDR Text Key: 287121258
• Report Number: MW5107987
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/08/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2023
• Device Lot Number: 210292
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female