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

Catalog Number 04625374160

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Coagulation Disorder (1779); Insufficient Information (4580)

Event Date 02/05/2021

Event Type  Injury  

Manufacturer Narrative

Medical assessment of the event concluded it is not possible to make a conclusion on the contribution of the coaguchek meter based on currently available information.Based on the provided information the patient was not treated based on the inr result discrepancy already observed on (b)(6) 2021, four days before the scheduled medical procedure and the confirmation of the blood clot with tee on (b)(6) 2021.The medical procedure was scheduled to "fix her mitral valve".The elevated thromboembolic risk was already indicated by the inr 1.9 from the lab on (b)(6) 2021.The inr from coaguchek meter at that time was 2.6 inr, slightly above the lower end of the patient's therapeutic range.The underlying disease being the indication of anticoagulation (mitral valve replacement) is associated with elevated thromboembolic tendency.The occurrence of a thromboembolic event is not completely excluded even if inr is within the therapeutic range, especially at the lower end.Immediate adaption of the anticoagulation treatment (increase vka drug dose often combined with a shot of heparin) belongs to essential management for the prevention of thromboembolic events.The blood clot was confirmed on (b)(6) 2021.The patient's medical history (mitral valve replacement/heart valve disease, lymphoma) and treatment with copiktra, an antineoplastic drug, with a known side effect of anemia (45%-55%, acc.Drug monograph) raise concerns about existing anemia.To evaluate whether there might be a potential interference of hematologic parameters on the performance of the meter, additional information on the hemogram of the patient has been requested.No further information has been received at this time.The reporter's meter and test strips were 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.Test strip retention samples passed the internal inspection.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.Medwatch field udi number = (b)(4).Medwatch field occupation - the occupation is lay user/patient.

Event Description

The initial reporter stated that a patient received discrepant results when testing with coaguchek xs meter serial number (b)(4).On (b)(6) 2021, the patient was tested in the laboratory as part of pre-surgery admission.At 11:00 a.M.On (b)(6) 2021, a sample from the patient was tested in the laboratory using an unknown method, resulting in a value of 1.9 inr.At 2:00 p.M.On the same day, a sample from the patient was tested using the meter, resulting in a value of 2.6 inr.The patient's warfarin schema was not changed based on results obtained on (b)(6) 2021.At 5:00 a.M.On (b)(6) 2021, a sample from the patient was tested using the meter, resulting in a value of 3.0 inr.At 6:15 a.M.On the same day, a sample from the patient was tested in the laboratory using an unknown method, resulting in a value of 1.3 inr.The patient was supposed to have a procedure performed on (b)(6) 2021, but a blood clot was found when a transesophageal echocardiogram (tee) was performed on the patient prior to the procedure.The patient was told to take warfarin and lovenox.No other treatment was needed.The patient's warfarin dose was increased to "10" every day for the next three days.The patient's therapeutic range is 2.5 - 3.0 inr.The patient's testing frequency is daily.

• 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: 11454588
• MDR Text Key: 243286912
• Report Number: 1823260-2021-00742
• Device Sequence Number: 1
• Product Code: GJS
• 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: 03/10/2021

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 Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/10/2021
• 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): Other
• Patient Age: 71 YR