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

Model Number	COAGUCHEK INRANGE
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Gastrointestinal Hemorrhage (4476); Insufficient Information (4580)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
We received an allegation that the coaguchek vantus meter may have contributed to a patient's gastrointestinal (gi) bleeding.The reporter initially called because the meter was allegedly not working and the nurse was unable to complete the test.The meter log was checked and the following errors were noted: m-42, m-26, e-68, and m-31.During the call, the reporter also mentioned that the patient was just recently released from the hospital due to gi bleeding.The last meter result prior to the alleged gi bleeding was on (b)(6) 2022.The meter result on (b)(6) 2022 from the meter memory was reported to be > 6.0 inr.The patient reportedly skipped warfarin for 3 days "and then half a pill" based on this result.The reporter stated that the patient did not test on the meter in (b)(6) 2022 and also did not have home health do tests on the meter.The reporter stated that the patient had home health do a venous draw to test inr in (b)(6) 2022, but did not receive results until after the patient was admitted to the hospital.The reporter stated that on (b)(6) 2022, the patient was very pale and had a black bowel movement.The patient reportedly had iron and "pepto" which the reporter stated could also cause black bowels.The next morning, the patient reportedly had another black bowel movement but was tinged with blood.An ambulance was reportedly called and the patient was reportedly admitted to the hospital for a gi bleed and was very anemic.The patient was reportedly placed in the intensive care unit (icu) and had four blood transfusions, a colonoscopy, and an endoscopy.The cause for the bleeding was reportedly not found.The patient was reportedly hospitalized starting (b)(6) 2022 until (b)(6) 2022 when the patient was released.The reporter stated that she does not know what the inr was while in the hospital, but stated that the hospital wanted the patient's inr inr to be around 2.0 inr at release.The patient's therapeutic range was requested but not provided.The interval of testing is reportedly weekly after the hospital stay.The test strip lot number is 63657521.The expiration date was requested but not provided.This mdr is being submitted with an abundance of caution.
Additional Manufacturer Narrative
The test strips are no longer available for investigation.The meter was requested for investigation.A follow-up report will be submitted when the meter is returned.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and the results have passed the internal inspection.  per product labeling: "coaguchek method uses human recombinant thromboplastin.Therefore, the comparability to tests using other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastin types.However, those higher differences between thromboplastins of different (rabbit, bovine) origin are not an issue specific for coaguchek assays.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared with several other (rabbit, bovine) laboratory methods."  the following errors were noted from the meter log: m-42, m-26, e-68, and m-31.Product labeling states: "sample too small [m-42] not enough sample was applied.Repeat test with a new test strip." "power failure [e-68] there was an unexpected interruption of the meter's power supply.Repeat your last procedure." "test strip error [m-26] test strip removed during test.Repeat test with a new test strip." "batteries empty [m-31] batteries are nearly empty.Replace batteries now." occupation: patient/consumer.The reporter is the patient's daughter.
Additional Manufacturer Narrative
In mfr report ref #1823260-2023-00419-00, "b5 - describe event or problem" should have been: "we received an allegation that the coaguchek vantus meter may have contributed to a patient's gastrointestinal (gi) bleeding.The reporter initially called because the meter was allegedly not working and the nurse was unable to complete the test.The meter log was checked and the following errors were noted: m-42, m-26, e-68, and m-31.During the call, the reporter also mentioned that the patient was just recently released from the hospital due to gi bleeding.The last meter result prior to the alleged gi bleeding was on (b)(6) 2022.The meter result on (b)(6) 2022 from the meter memory was reported to be > 6.0 inr.It was reported that the patient skipped warfarin doses for 3 days and then took a half pill of warfarin based on the result.The reporter stated that the patient did not test on the meter in (b)(6) 2022 and also did not have home health service do tests on the meter.The reporter stated that the patient had a home health nurse perform a venous draw to test inr on (b)(6) 2022, but did not receive results until after the patient was admitted to the hospital.The reporter stated that on (b)(6) 2022, the patient was very pale and had a black bowel movement.The patient reportedly had iron and "pepto" which the reporter stated could also cause black bowels.The next morning, the patient reportedly had another black bowel movement but was tinged with blood.An ambulance was reportedly called and the patient was reportedly admitted to the hospital for a gi bleed and was very anemic.The patient was reportedly placed in the intensive care unit (icu) and had four blood transfusions, a colonoscopy, and an endoscopy.The cause for the bleeding was reportedly not found.The patient was reportedly hospitalized starting (b)(6) 2022 until (b)(6) 2022 when the patient was released.The reporter stated that she does not know what the inr was while in the hospital.The reporter stated that the hospital wanted the patient's inr to be around 2.0 inr at release.The patient's therapeutic range was requested but not provided.The interval of testing is reportedly weekly after the hospital stay.The test strip lot number is 63657521.The expiration date is jan-2024.This mdr is being submitted with an abundance of caution.".

• 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: 16344562
• Report Number: 1823260-2023-00419
• Device Sequence Number: 6836923
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: COAGUCHEK INRANGE
• Device Catalogue Number: 07729952160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WARFARIN.
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Other
• Patient Age: 83 YR
• Patient Sex: Female