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

Catalog Number 04625358003

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation is lay user/patient.This event occurred in (b)(6).

Event Description

The customer complained of an erroneous high inr result on coaguchek xs meter serial number (b)(4) compared to an unspecified laboratory method.At 9:00 a.M.The result from the meter was 4.3 inr.At 10:00 a.M.The result from the laboratory was 2.8 inr.The customer's therapeutic range is 2.5 - 3.5 inr.There was no allegation that an adverse event occurred.

Manufacturer Narrative

The customer did not return any materials for investigation.The complained test strips have been calibrated against the who standard rtf/16 and are affected by recall.Corresponding retention test strips (lot 294946) were tested in comparison to masterlot #28632180 (recalibrated lot to rtf/09).The corresponding retention material complies with the specification, based on requirements of the regular retention testing process of the qc department.The retention material and comparable masterlot test strips did not show abnormalities.Investigations have indicated results are reliable from 0.8 to 4.5 inr, since the calibration data covers this measuring range very well.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: 8203892
• MDR Text Key: 131772610
• Report Number: 1823260-2018-05167
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

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: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 04625358003
• Device Lot Number: 294946
• 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: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALUPURINOL; DEKRISTOL - EVERY 14 DAYS; FALITHROM; METOPROLOL; SIMVASTATIN; SPIRUNULACTON; THORASEMID
• Patient Age: 60 YR