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

Catalog Number 04625315160

Device Problem High Test Results (2457)

Patient Problems Pain (1994); Numbness (2415); Thrombosis/Thrombus (4440)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

The test strips were provided for investigation where they were tested using a reference meter with high-level control samples.Testing results (qc range = 4.1 - 6.8inr): qc 1: 5.1 inr, qc 2: 5.0 inr, qc 3: 5.1 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.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 laboratory method used was reportedly a stago reagent on a sysmex analyzer.Per product labeling, "coaguchek uses human recombinant thromboplastin.Therefore, the 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." the patient was taking clopidogrel.Per product labeling, there is no significant effect on test results for clopidogrel up to 20 mg/dl.

Event Description

There was an allegation that a patient suffered a clot behind his left knee and that his coaguchek meter serial number (b)(4) is not providing accurate results.The patient reportedly has lupus anticoagulant syndrome.Per product labeling, "the presence of anti-phospholipid antibodies (apas) such as lupus antibodies (la) can potentially lead to prolonged clotting times, i.E., they may cause false-high inr values.If you have or suspect that you have apas, contact your doctor and do not continue inr testing with this device." this apa limitation was discussed with the reporter.On (b)(6) 2021, the patient complained of having pain and numbness in the left leg behind the knee.An abi (ankle brachial index) test was performed which was 0.4 in the left leg and 0.75 in the right leg.On (b)(6) 2021, the patient visited the cardiologist for an echo and a doppler that reportedly confirmed a thrombus in the left leg behind the knee.On (b)(6) 2021, the patient was admitted to the hospital and was released on (b)(6) 2021.While in the hospital, the patient was treated with two stents and was given vitamin k, fresh frozen plasma, enoxaparin, and a heparin drip.The dosages of these medications were not provided.Allegedly, the clot may have originated from the heart and it was alleged that the clot formed because he was given an incorrect dosage of medication due to the meter not reading accurately.The patient's inr results prior to the event were allegedly all within the patient's therapeutic range and between 2.0-3.0 inr and the patient was taking his normal warfarin dose of alternating days of 7.5mg and 5mg.It was alleged that because the patient's inr from the laboratory was actually lower than the meter reading, the patient's therapeutic range was changed from 2.0-3.0 inr to 3.0-4.0 inr and his warfarin dose was increased to alternating days of 12.5 mg and 10 mg on (b)(6) 2021.The patient also started taking clopidogrel, vascepa, and aspirin.The patient's testing frequency was changed from every 3 weeks prior to the event to weekly.The last 5 meter results reportedly 3 weeks apart were: 3 weeks prior to the event the meter result was reportedly 2.4 inr.3 weeks prior to the previous result, the meter result was reportedly 2.8 inr.3 weeks prior to the previous result, the meter result was reportedly 2.5 inr 3 weeks prior to the previous result, the meter result was reportedly 3.2 inr, 3 weeks prior to the previous result, the meter result was reportedly 2.6 inr.The specific date and time of these results were not provided.No results were present in the meter memory and the memory may have been cleared.The laboratory method was reportedly a stago reagent on a sysmex analyzer.The patient reportedly feels better.

• 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: 12656483
• MDR Text Key: 277379721
• Report Number: 1823260-2021-03036
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702128101
• UDI-Public: 00365702128101
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 04625315160
• Device Lot Number: 49017411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2021
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 27 YR