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

Catalog Number 04625315019

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).This event occurred in (b)(6).

Event Description

The nurse complained of discrepant inr results for 1 patient on a coaguchek xs meter.The coaguchek xs meter serial number was asked for but not provided.The initial result from the meter was 7.6 inr with a flashing "c".The second result from the meter was 6.1 inr with a flashing "c".The third result from the meter was >8.0 inr with a flashing "c".The fourth result from the meter was 3.0 inr.There was no allegation of an adverse event.The nurse described the samples as "very watery".The nurse stated that they did not squeeze the finger.The nurse stated, "that the blood drop did not look like blood but almost like water".The first three results were measured from the same hand.The fourth measurement was from a different hand.The qc before the measurements passed.The qc was tested after the measurements.The patient's therapeutic range was 2 - 3 inr.It was asked but not known if the customer was taking anticoagulant medication.The suspect product was requested to be returned for investigation.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.Retention material complies with specification.

Manufacturer Narrative

The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7569062
• MDR Text Key: 110123915
• Report Number: 1823260-2018-01746
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 04625315019
• Device Lot Number: 29494211
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1