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

Catalog Number 04625374160

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Hemorrhage, Subdural (1894); Seizures (2063)

Event Date 04/27/2015

Event Type  Injury  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).No product is expected for return since we don't have the customer's contact information.

Event Description

The customer's lawyer filed a lawsuit alleging that the coaguchek meter (serial number not provided) produced "false and inaccurate" inr results causing her "irreversible and severe injuries." the lawsuit states that "at all relevant times" the coaguchek meter produced results within the customer's therapeutic range.The customer's therapeutic range was not provided.Specific meter results and actions taken based on the meter were not provided.The only information roche has concerning this incident is from the lawsuit.The customer did not contact roche with this complaint.Roche has no further information related to this incident.The lawsuit states that around (b)(6) 2015 the customer started to have severe headaches.On approximately (b)(6) 2015 the customer suffered "multiple injuries" including a seizure and a subdural hematoma.On (b)(6) 2015 the customer underwent an emergency craniotomy to treat the "life-threatening subdural hematoma." the lawsuit states that the customer has had complications on a daily or persistent basis after the subdural hematoma of "aphasia, facial droop, severe headaches, double vision or blurry vision, gastrointestinal bleeding, uncontrollable shaking, difficulty with motor skills, cognitive dysfunction and undesirable side effects of multiple forms of medications to treat these issues." the customer's lawyer states that since the customer relied on the "false and inaccurate" results from the coaguchek meter, this prevented her from taking necessary actions to control her inr results.The lawsuit states that if the coaguchek meter had "safely and reliably" measured the customer's inr, the customer could have made medication adjustments to prevent the "severe injuries and irreversible harm." the lawsuit states that the customer's doctors "determined that the seizure and subdural hematoma were caused by over-coagulation of her blood." since the customer has not contacted roche directly, and we only have the city and state where she resides, we are not able to request the suspect product for return.No product is expected for return to complete the investigation.

Manufacturer Narrative

No information was provided in the complaint that would point to a cause for the alleged results.Since no product was returned, the investigation cannot be completed.

Manufacturer Narrative

The customer returned the meter and test strips.The test strips were expired and could not be tested.The coaguchek xs meter serial number was (b)(4).Lot number and expiration date were updated.The returned meter was tested in comparison to a retention meter and master lot strips.Human blood samples from warfarin donors were used.Donor 1 inr: 2.2 inr , donor 2 inr: 3.2 inr.Donor 1 hct: 47% , donor 2 hct: 54%.Donor 1: retention meter with master lot strips: 2.2 inr, customer meter with master lot strips: 2.2 inr.Donor 2: retention meter with master lot strips: 3.1 inr , customer meter with master lot strips: 3.1 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned material and the retention material meet the specifications.The customer's returned meter was additionally tested with controls: qc 1: 2.6 inr , qc 2: 2.6 inr.The obtained qc values were in the allowed range of the used combination master lot strip lot - qc lot.(2.2 - 3.4 inr).All measurements were obtained without error messages.The investigation was unable to find a definitive root cause for this event.

• 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: 6067592
• MDR Text Key: 58785042
• Report Number: 1823260-2016-01684
• 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: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/04/2018

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 Expiration Date: 02/29/2016
• Device Catalogue Number: 04625374160
• Device Lot Number: 230736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: Not provided; 10/18/2016; 10/18/2016
• Supplement Dates FDA Received: 12/12/2016; 09/06/2017; 06/04/2018
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention