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

Catalog Number 04625315160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2018

Event Type  malfunction  

Event Description

The customer stated that they received an erroneous result for one patient tested with a coaguchek xs meter (unknown serial number).The specific date of the event is not known.The customer stated that the event occurred a few weeks prior to (b)(6) 2018.A sample from the patient was tested using the meter, resulting with a value of 5.9 inr.Another sample was immediately collected from the patient and tested in the laboratory on a stago analyzer using neoplastin+ reagent, resulting with a value of either 3.2 inr or 3.5 inr.No adverse events were alleged to have occurred with the patient.The customer did not know if the patient had any limitations for usage of the meter.The customer did not know the patient's therapeutic range and did not know if the patient had any symptoms of bleeding or bruising.The customer did not know if the patient required treatment.The customer's product was requested for investigation.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.

Manufacturer Narrative

The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.Coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods.

• 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: 8203948
• MDR Text Key: 131718803
• Report Number: 1823260-2018-05170
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04625315160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/17/2018
• Supplement Dates FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1