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

Catalog Number 03666794689

Device Problem Unable to Obtain Readings (1516)

Patient Problem Death (1802)

Event Date 08/10/2015

Event Type  Death  

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.

Event Description

The representative from alere reported on (b)(6) 2015 that the patient received an error 7 on the coaguchek xs system.The caller was advised that the reported error 7 is a measurement error caused by the blood sample and it could mean an inr result that is higher than the meter measuring range (highest reading is 8.0 inr) which would indicate a long coagulation time.The alere representative was told that an alternative test method should be sought.The alere representative acknowledged this information and stated they will have her tested in another way.Another alere representative called on (b)(6) 2015 and reported that the patient passed away that morning.The patient's daughter was contacted and stated her mom went to the hospital on (b)(6) 2015 and was admitted to the hospital due to internal bleeding.The patient did not receive medical treatment; she was transferred to hospice service because she was a do not resuscitate (dnr) patient, and passed away on (b)(6) 2015.No information regarding if or why not any lab result was sought on (b)(6) 2015.Her therapeutic range was 2.0 inr to 3.0 inr.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: 5057508
• MDR Text Key: 25050746
• Report Number: 1823260-2015-04098
• 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 Family Member or Friend
• Report Date: 09/24/2015

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: 08/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2015
• 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
• Patient Outcome(s): Death
• Patient Age: 072 YR
• Patient Weight: 95