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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 10/27/2021

Event Type  Injury  

Manufacturer Narrative

The customer's meter and test strips were requested for investigation.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 reporter's meter and test strips were provided for investigation.However, the customer's returned strip vial was empty with no more useable test strips.Therefore, the reporter's returned meter was tested with retention strips and retention controls.Testing results (qc range = 2.3 - 3.5 inr): qc 1: 2.9 inr, qc 2: 2.9 inr, qc 3: 2.9 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.Per product labeling: "coaguchek uses human recombinant thromboplastin.Therefore, comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods." occupation - the occupation is patient/consumer.

Event Description

It was alleged that a patient had a blood clot while using coaguchek xs meter serial number (b)(4).It was also alleged that the patient received a questionable result when testing with the meter.The actual date and time of the alleged event are unknown.The patient went to the emergency room for an alleged blood clot in her left leg and a strained muscle in her right leg.The patient was not admitted to the hospital.It was alleged that the treating physician did not know what caused the blood clot but was concerned about the variance observed between meter and laboratory tests.The patient had two ultrasound procedures performed.The patient confirmed that the blood clot in her left leg was a deep venous thrombosis (dvt).At an unknown date and time, a venous sample collected from the patient was tested in the laboratory using an unknown method, resulting in an alleged value of 1.6 inr.The patient's warfarin dosage was believed to have been increased based on this value, however, this is not known for sure.The warfarin dosage increase was used to treat the patient's blood clot.The patient reportedly received no other treatment for the blood clot.At an unknown time on (b)(6) 2021, a sample from the patient was tested using the meter, resulting in an alleged value of 2.7 inr.No therapeutic changes were made based on this value.Upon review of the meter's patient result memory, it was determined the date and time of the meter had been set incorrectly by the patient.This meter measurement was alleged to have occurred on (b)(6) 2021, but the meter recorded a date of (b)(6) 2021.The patient's therapeutic range is 2.0 - 3.0 inr.The patient's testing interval is bi-weekly.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12916365
• MDR Text Key: 286596530
• Report Number: 1823260-2021-03560
• 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: K062925
• 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: 12/02/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 51508621
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 12/02/2021
• 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: COLESTIPOL HCL; ISOSORBIDE MONONITRATE (TABLETS); KLOR-CON; LOSARTAN / HYDROCHLOROTHIAZIDE; SERTRALINE; TIADYLT ER; WARFARIN SODIUM
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 119 KG