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

Catalog Number	07729952160
Medical Device Problem Codes	Circuit Failure (1089); No Device Output (1435); High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Easy Bruising (4558)
Date of Event	10/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
We received an allegation that a patient was unable to test on their coaguchek xs meter between (b)(6) 2023 and (b)(6) 2023 which may have led to the hospitalization and treatment for vitamin k.The patient reportedly attempted to test several times between (b)(6) 2023 and (b)(6)2023 and received error m-44 on the meter.On (b)(6) 2023 at 10:42 am the patient reportedly tested again and received a meter result of 4.9 inr.Around 4 pm the patient allegedly went to the emergency room due to not feeling well and having a knot in his pelvis.The patient's laboratory result was reported to be high.The patient had a bruise on his abdomen and was diagnosed with an internal pelvic bleed.The patient was hospitalized for 4 days.The patient was allegedly treated with an intravenous vitamin k.The patient¿s therapeutic range was 2.5 inr and the interval of testing was weekly.
Additional Manufacturer Narrative
The coaguchek xs test strips' lot number was 70302321 with an expiration date of 31-oct-2024.The meter and test strips have been 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.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.The patient reported receiving error m-44.Product labeling states: in rare cases, patients with abnormal or unusually long clotting times may receive m-44 or w-45 error messages.Repeat test with a new strip.If m-44 or w-45 error messages display repeatedly, you must use an alternative test method to confirm the result.Please contact your physician without delay.
Additional Manufacturer Narrative
Section d9 was updated.The medical device problem codes were updated.The meter was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 2.8 inr qc 2: 2.7 inr qc 3: 2.7 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 investigation did not identify a product problem.The returned meter meets the specifications.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18231499
• Report Number: 1823260-2023-03792
• Device Sequence Number: 5366222
• Product Code: GJS
• UDI-Device Identifier: 00365702700499
• UDI-Public: 00365702700499
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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: Lay User/Patient
• Device Catalogue Number: 07729952160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/22/2023
• 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: ALBUTEROL PRN FOR CONGESTION.; ALLOPURINOL.; DILTIAZEM.; ERGOCALCIFEROL.; FENOFIBRATE.; FISH OIL.; FLONASE.; GABAPENTIN.; IRON.; LANTUS.; LUBRICANT EYE DROPS.; MAGNESIUM.; PEPCID.; PLAVIX.; PRESERVISION.; VITAMIN B12.; VITAMIN C.; VITAMIN D3.; WARFARIN.; ZINC.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 98 KG