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 Problem Coagulation Disorder (1779)

Event Date 06/26/2017

Event Type  Injury  

Manufacturer Narrative

The medical assessment concluded that a "possible clot in distal vessel cutoff with reconstruction" is plausible to the underlying complicated heart functionality of the patient.The patient suffers from a-fib-tachy brady, st jude artificial heart valve, congestive heart failure and mild/moderate mitral regurgitation / depressed left ventricular systolic function moderate.These underlying diseases are directly associated with elevated thromboembolic risk and indication for anticoagulation therapy.However the anticoagulation therapy (vka/warfarin and antiplatelet /plavix), is not causal treatment for the underlying diseases but serves to keep thromboembolic risk as low as possible and cannot completely exclude or prevent a thromboembolic event.Without any inr results in the time frame (b)(6) 2017 and no inr comparison results from the lab/hospital at the time of admission it is not possible to assess if and to what extent the performance of the device might have contributed to the alleged event of heart attack.It is unlikely that the coaguchek meter caused or contributed to the bleeding the patient experienced during hospitalization.The bleeding can be very likely attributed to the administration of heparin, given in the context of the heart attack.Bleeding is a known side-effect of heparin.Blood thinners are included in the therapeutic regimen of a heart attack following the immediate measures.The bleeding was treated effectively with vitamin k.The customer¿s products were requested for return.It was reported the customer no longer has the meter or strips.Routine retention testing was performed and was acceptable.Retention testing data is reviewed and appropriate actions are taken as needed.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." occupation was lay user/patient.

Event Description

We have received an allegation that a patient using coaguchek xs meter serial number (b)(4) had a heart attack due to a blood clot in her heart caused by an incorrect result.On (b)(6) 2017, the meter result was 4.0 inr.It was stated the inr was high and the patient ate a salad that day but does not remember if she made any changes to her warfarin dose.No information regarding inr results, medication, or diet changes between (b)(6) 2017 and (b)(6) 2017 was provided.On (b)(6) 2017, the patient noticed a pain in their chest and jaw and was driven to the er.The exact time could not be verified but is believed to have been between 2:00-3:00 pm.It is reported that when the patient arrived at the er, they took the patient¿s blood and said "something isn't right" so they kept the patient there.An ecg was performed in the er but the findings were not provided.No diagnostic information was provided, but it was confirmed that the diagnosis of heart attack was made.At 12:30 am the patient was woken up to take nitroglycerin and asked if she was having a heart attack.The healthcare professional said "yes" and they had to transport the patient by ambulance to another hospital since they were unable to treat her.The cardiac enzymes were stated as "12.5." no further diagnostic information could be provided.The patient arrived at the second facility, where the patient was told they needed a cardiac catheterization which they could not do so the patient was sent to a third hospital.At the third hospital, it was reported the patient's "enzymes were 22".No further diagnostic information could be provided.The doctor suspected a blockage but performed an angiogram and couldn't find a blockage so a cardiac catheterization was performed.The findings showed "possible clot in distal vessel (cutoff with reconstitution seen) 3rd om." the heart catheterization confirmed a "non-obstructive coronary artery disease" and concluded to moderate mitral valve insufficiency.No findings were plausible to a heart attack.It was reported that the patient thought they gave her vitamin k as she bled a lot.The inr value at the time of the bleeding was unknown.Whether vitamin k was given before or after the angiogram or before or after the catheterization procedure is unknown.It is believed that the patient received heparin during this time frame but it is not known for sure.It was reported the patient was in icu for approximately 2-3 days after the procedure and then in a regular room for a day or two.The patient currently "feels good/strong".The therapeutic range was 2.5-3.5 inr and the patient tests twice a month.

• 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: 11310603
• MDR Text Key: 238340443
• Report Number: 1823260-2021-00419
• 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: 02/10/2021

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/10/2021
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 64