MAUDE Adverse Event Report: ROCHE DIAGNOSTICS, GMBH COAGUCHEK VANTUS AND TEST STRIPS; TEST, TIME, PROTHROMBIN

Lot Number STRIPS- 39739621

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

Patient Problem Test Result (2695)

Event Date 10/06/2019

Event Type  Injury  

Event Description

After receiving a result 6.0 on 10/06 using the roche "coaguchek vantus" inr testing device and test strips i shortly received a call from ther automated notification service advising that my results were out of range but these results could not be reported to my physician due to the time being out of business hours (a weekend).Accordingly i contacted my physician who advised not to take my normal warfarin dose that evening.On 10/07 at 0830 am my physician called to advise me to take another test with the roche system.Results from that test were again 6.0.My physician advised me to go to a (b)(6) testing lab to draw blood and perform another test.I immediately went to (b)(6) for the blood draw.Later in the afternoon of 10/07 i received a lab results reporting an inr of 5.0.Why was the coaguchek vantus off by one full point reporting an inr of 6.0 when subsequent lab test reported as 5.0? further on 10/07 i did not get a call back from roche (on a 0830 am test) until 1900 pm to report they could not transmit or notify my physician until (10/8) due to the fact it was out of normal business hours.Why did it take until 1900 pm to get a call back? the roche coaguchek vantus meter is unreliable and inaccurate, test strips are not forgiving often requiring several attempts for appropriate placement of blood on the test strip often requiring use of multiple test strips and thus increasing the need to order strips more frequently.Ther are too many issues using an unreliable and unsafe inr test device, faulty test strips and untimely reporting services.Meter: coaguchek vantus, test strips: coaguchek xs pt test, ref: (b)(4), gtin: (b)(4), ref: (b)(4), sn: (b)(4), exp: 10/31/2020, lot: 39739621, gtin: (b)(4).Above is the resulting blood work results from (b)(6) over 3 days (missing dosage of 3 mg/day dosage) and used to validate the issue of high reading (6.0) report from roche device.Fda safety report id# (b)(4).

• Brand Name: COAGUCHEK VANTUS AND TEST STRIPS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS, GMBH
• MDR Report Key: 9193149
• MDR Text Key: 162633700
• Report Number: MW5090389
• 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: 10/09/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/31/2020
• Device Lot Number: STRIPS- 39739621
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 66 YR
• Patient Weight: 95