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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem Ischemia Stroke (4418)

Event Date 02/03/2023

Event Type  Injury  

Event Description

The initial reporter alleged the patient had a stroke while using coaguchek xs meter serial number (b)(6).The reporter alleged it was hard for the patient to talk and he was mumbling.The patient's wife allegedly took him to the hospital.The result reported to be from the hospital laboratory using an unknown regent was 1.1 inr.The reporter alleged the patient had a stroke.The patient was reportedly given medication via iv for the stroke that should have been taken within one hour of having the stroke.The reporter did not know the name of the medication.The reporter did not think "they did anything else" while the patient was in the hospital.The patient's inr was reportedly monitored until it returned to normal.No other treatment information or inr results from the time of the event could be provided.The patient was allegedly in the hospital for 3 days and was given a prescription for lovenox.The patient's current condition was reported to be "feeling ok".The therapeutic range was 2.5-3.5 inr and the testing frequency was every 2 weeks.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

The reporter's meter was provided for investigation where it was tested using retention strips and controls.The test strips were not returned.Testing results (qc range = 2.3 ¿ 3.5 inr): qc 1: 2.9 inr, qc 2: 3.0 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.The results alleged by the customer were observed in the meter¿s patient result memory.However, the date and time were not set correctly.The patient mentioned receiving error 5 and error 6 "in the past." a review of the meter error log revealed error 5.Error 5 occurs when the applied sample volume is insufficient or when sample detection is uncertain.Generally, this is caused by wrong handling, or by meter contamination.Per product labeling for error 5: error applying blood to the test strip.Turn the meter off and remove the test strip.Repeat the test using a new test strip and blood taken from a new fingerstick from a different finger.A review of the meter error log revealed error 6.Error 6 is triggered if a wet test strip was used, or the strip was already used before and reinserted.Per product labeling for error 6: the test strip was touched or removed during the test.Turn the meter off and remove the test strip.Repeat the test using a new test strip and blood taken from a new fingerstick from a different finger.Do not touch or remove the test strip when a test is in progress.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.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 investigation did not identify a product problem.The cause of the event could not be determined.E3 - occupation was patient/consumer h3 other text : na.

• 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: 16964198
• MDR Text Key: 315583863
• Report Number: 1823260-2023-01691
• 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: 05/19/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: 66283812
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/19/2023
• 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: WARFARIN.
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 113 KG