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 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

[mw5081790].

Event Description

This event was reported by the customer to fda as mw5081790.The customer complained of discrepant inr results for 1 patient tested on a coaguchek xs meter with an unspecified serial number compared to an unspecified laboratory method.The date of event is an approximation as the date of event was not provided.The result from the meter was > 6 inr.The actual result was not provided.The result from the laboratory was "in the 3 range" inr.The actual result was not provided.There was no allegation that an adverse event occurred.The complained test strips have been calibrated against the who standard and are in scope of the roche initiated recall.For these test strips there is a potential for a product problem when the inr is > 4.5.Values > 4.5 inr showed an increasing positive bias.The information in the case is consistent with the details of the recall and the issue has been fully investigated.

Manufacturer Narrative

Coaguchek uses human recombinant thromboplastin.Therefore, 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: 8204054
• MDR Text Key: 131772357
• Report Number: 1823260-2018-05171
• 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: 04/25/2019

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: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES Z-0360-2019
• Patient Sequence Number: 1
• Treatment: WARFARIN SODIUM