MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK VANTUS; PROTHROMBIN TIME MONITOR

Model Number COAGUCHEK INRANGE

Device Problem Circuit Failure (1089)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

The meter was requested for investigation.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 is lay user/patient.

Event Description

The initial reporter stated they obtained a result on a coaguchek vantus meter with a 396 code key while using a strip lot that should only work with a 400 code key.Instead of producing a result, the meter should have produced an error.At 4:00 pm the meter result 1.6 inr was obtained while using alleged 396 code key and test strips lot 40501421 (400 code).The customer stated that she has a corresponding code key 400 for each bottle of 400 code strips, however she had never changed the code key from 396 since she started using the meter.She only changed the code key to 400 after obtaining the 1.6 inr result on (b)(6) 2020.The customer¿s therapeutic range is 2.0 - 3.0 inr.

Manufacturer Narrative

Sections d10 and h3 were updated.The customer's meter was returned.Investigation results: the wrong combination of test strips and code key is always recognized and [i-03] is displayed (wrong code chip.).No measurement results can be obtained with the wrong code chip data.Since the device saves the code chip data when it is used correctly for the first time, this stored data would be queried after the insertion of a test strip.The required 'correct' code chip data is available.An inserted 'wrong' code chip is therefore no longer read out and recognized as incorrect.In this case, the measurement was started immediately with the correct data.It was observed in the returned meter memory that a measurement had already been carried out with code chip # 400, and the data was stored in the device.The alleged test results were carried out with the correct code chip.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COAGUCHEK VANTUS
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9785995
• MDR Text Key: 220564434
• Report Number: 1823260-2020-00629
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: COAGUCHEK INRANGE
• Device Catalogue Number: 07729952160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR