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 Blood Loss (2597)

Event Date 12/31/2020

Event Type  Injury  

Manufacturer Narrative

The medical assessment of the event concluded that the information does not reasonably suggest that the meter caused or contributed to the event because the most recent meter results provide are from 2019, one year prior to the event.Also, there were no inr results provided on the meter around the time of the event and there was no laboratory to meter comparisons provided.It was reported that the patient has anemia.In general, anemia may be a risk factor for out-of-range inr.The patient's hemoglobin and hematocrit levels were not provided.The date and time were set correctly in the meter.The customer¿s meter and test strips were requested for return, but the customer's test strips are not available for investigation.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.Product labeling states: "the coaguchek method uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas deviations can occur when compared to methods using other thromboplastins.However, those deviations between thromboplastins of different origin (e.G., rabbit based) are not specific to coaguchek products.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared to other laboratory methods." occupation is lay user/patient.

Event Description

We have received an allegation of inaccurate results with the coaguchek xs meter serial number (b)(4) which contributed to a bleeding event and hospitalization.It was alleged that the meter was 3 or 4 points off from a laboratory methodology but the comparison values could not be provided and it was stated there may have been a few days in between comparison tests.The only inr results provided from the meter were from 1 year prior to the event.Prior to the event, the patient was taking 5 mg of warfarin, and there were no changes in dose, diet, or health.The exact date of hospitalization could not be provided but the patient was admitted for one night at the end of (b)(6).The patient had gone to the emergency room and had a high inr result, but the inr result was not high enough to require medical treatment and was discharged.The next day, it was reported that the patient passed out while driving.The patient was taken to the emergency room and had a laboratory inr result of 7.6 inr and blood in his stool.The patient received one unit of blood, had an endoscopy and colonoscopy performed, and it was discovered that he had a non-cancerous polyp, but the source of bleeding was unable to be found.The patient did not require surgery to stop the bleeding event.The patient¿s current condition is stable and the bleeding has stopped.The customer's therapeutic range was 2.0- 3.0 inr and tests every two weeks.

• 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: 11318071
• MDR Text Key: 234996690
• Report Number: 1823260-2021-00435
• 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: 02/11/2021

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: 01/13/2021
• Initial Date FDA Received: 02/11/2021
• 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
• Patient Age: 74 YR
• Patient Weight: 98