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

Model Number	COAGUCHEK INRANGE
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation is patient/consumer.The meter and strips were requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of a software issue with a coaguchek vantus meter.The meter showed a duplicate result in the meter memory.The patient only tested one time on (b)(6) 2022.The meter memory showed the following results.On (b)(6) 2022 the meter result was 4.3 inr at 15:57.On (b)(6) 2022 the meter result was 4.3 inr at 16:03.The result was reported and the patient was advised to hold warfarin for 2 days.There were no negative effects from holding medication.The patient's therapeutic range is 2.5-3.5 inr.The test strip lot number is 49682521 with an expiration date of 30-apr-2022.
Additional Manufacturer Narrative
The reporter's meter was provided for investigation where they were tested using retention strips and controls.Testing results (qc range = 4.1 ¿ 6.8 inr): qc 1: 5.3 inr, qc 2: 5.3 inr, qc 3: 5.2 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The meter did not run slow.The results measured on (b)(6) 2022 were measured on the meter 46 minutes apart and there were two different entries as expected in the strip counter (nb.86 and 87).Medwatch fields d9 and h3 have been updated.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14119330
• Report Number: 1823260-2022-01065
• Device Sequence Number: 4334559
• 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): 05/31/2022

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 Model Number: COAGUCHEK INRANGE
• Device Catalogue Number: 07729952160
• 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: 03/23/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 05/31/2022
• 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: Unknown