MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME TEST STRIPS

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem Thromboembolism (2654)

Event Date 09/27/2022

Event Type  Injury  

Manufacturer Narrative

Occupation is patient/consumer.The reporter¿s meter and strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 4.1 ¿ 6.8 inr): qc 1: 5.1 inr; qc 2: 5.2 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 results alleged by the customer were observed in the meter¿s patient result memory.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.

Event Description

There was an allegation that inr results from coaguchek inrange meter serial number (b)(4) may have contributed to the patient¿s admission to the hospital for low inr and treatment.The patient¿s therapeutic range at this time was reportedly 2.0 ¿ 3.0 inr.The patient¿s warfarin regimen at this time allegedly alternated between 8mg and 4 mg.The patient's testing frequency was reportedly originally planned for weekly but has changed to every "couple of days." on (b)(6) 2022 at 6:00 a.M.The meter result was reportedly 2.0 inr.On (b)(6) 2022 the patient allegedly stopped her warfarin dose and bridged with lovenox on (b)(6) 2022 in preparation for a procedure to fix the leakage around the mitral valve that was identified on a follow-up appointment from her open heart surgery that had been performed on (b)(6) 2022.On (b)(6) 2022 the patient reportedly went in for a transesophageal echocardiogram (tee) in preparation for the procedure.No leakage was found around the mitral valve but a blood clot was allegedly found.The result from an unknown laboratory method was reportedly 1.3 inr.The patient no longer needed the procedure, however, she was reportedly admitted to the hospital due to low inr.The patient was allegedly treated intravenously with a high-intensity heparin drip in addition to an unspecified dosage of warfarin.The patient was kept in the hospital until her inr was elevated.On (b)(6) 2022 the patient was discharged from the hospital with a reported lab result from an unknown method of 3.5 inr.Following this event, the patient¿s therapeutic range was changed to 3.0 ¿ 3.5 inr.The patient is currently in stable condition.This mdr is being submitted in an abundance of caution.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• 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: 15770814
• MDR Text Key: 303414293
• Report Number: 1823260-2022-03576
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 04625374160
• Device Lot Number: 58526222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARMOUR THYROID; FERROUS GLUCONATE; GARDEN OF LIFE MULTI VITAMIN - LONG TERM USE; GARDEN OF LIFE PROBIOTIC; METOPROLOL TARTRATE; MIRALAX - EVERY 3 DAYS; NOW CALCIUM- MAGNESIUM; NOW VITAMIN D 5000IU; SERTRALINE; TORSEMIDE; TRAZODONE; WARFARIN
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female