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

Catalog Number 03666794689

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2015

Event Type  Injury  

Event Description

The patient reported being unable to obtain an inr result on the coaguchek xs system due to a device error.The reported error (error 7) can occur when a patient has an inr result >8.0 inr.The following day the patient went to the hospital; a lab value returned as 14.5 inr and the patient was treated with 5 units of plasma and vitamin k.The patient's coumadin dose was held based on the lab value.The patient went home the same day as the incident.Requested return of suspect system and replacement was sent.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5057854
• MDR Text Key: 25059106
• Report Number: 1823260-2015-04107
• 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: Patient
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03666794689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: METHADONE
• Patient Outcome(s): Required Intervention
• Patient Age: 048 YR
• Patient Weight: 116