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

Model Number	COAGUCHEK INRANGE
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation is patient/consumer.The test strips with the lot number 62216021 was with an expiry of 31-dec-2023.The meter with serial number (b)(4) and the test strips with lot number 63657521 were requested for investigation.The products have not been received at this time.If the products are returned in the future, a follow up report will be submitted.
Event or Problem Description
We received an allegation of error m-44 for 1 patient tested with 4 different coaguchek vantus meters serial numbers (b)(4).An interference was suspected.On (b)(6) 2022 the patient had an error m-44 when testing on coaguchek vantus meter serial number (b)(4) with test strips lot number 62216021.On (b)(6) 2022 the patient had an error m-44 when testing on coaguchek vantus meters serial numbers (b)(4) with test strips lot number 63657521.The patient stated her doctor used a coaguchek xs meter and was able to test her with their xs meter and test strips without getting an error.The patient's therapeutic range was not provided.
Additional Manufacturer Narrative
The meter was provided for investigation.The investigation determined the following: the test measurements were partially aborted with m-44 (test strip failed the internal control).M-44 is usually an error which is triggered either by irregularities on the test strip or by the user, e.G.If the strip was moved during measurement or the blood was applied too early on the strip, before the test field is warmed up.The circuit board shows no contamination that could lead to the complained error.The test strip contacts showed no recognizable contamination that can affect the contact.Investigation by the test strips adapter (tsa) showed a crack in the stop bar for the test strip.This allows the test strip to be pushed in a little further and the test strip contacts a short-circuit.The tsa itself showed no damage caused by external forces.The device showed no customer mishandling/user error.A defect of the circuit board or an electronic component on the circuit board has been determined.The error was classified as a non-systematic error.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COAGUCHEK VANTUS
• Common Device Name: 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16158603
• Report Number: 1823260-2023-00133
• Device Sequence Number: 7507487
• Product Code: GJS
• UDI-Device Identifier: 00365702700499
• UDI-Public: 00365702700499
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2024
• Device Model Number: COAGUCHEK INRANGE
• Device Catalogue Number: 07729952160
• Device Lot Number: 63657521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female