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

Catalog Number 07671679190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2019

Event Type  malfunction  

Manufacturer Narrative

The country of origin is (b)(6).Occupation is lay user/patient.The complained test strips have been calibrated against the who standard rtf/16 and affected by recall.The corresponding retention test strips 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.Retention test strips were tested in comparison with the master lot coaguchek xs pt (ml 13 #286321-80 recal.Rtf/09).For this purpose, two human blood samples from marcumar donors and two internal reference meters were used.Retention samples were acceptable.No error messages occurred.

Event Description

The initial reporter complained of a discrepant inr result with coaguchek inr meter serial number (b)(4) when compared to a laboratory result using an unknown method.The meter result was 5.5 inr (followed by a control bottle symbol).The meter result was 4.4 inr and the laboratory result was 3.0 inr.The patient was given calpol.The patients therapeutic range is 3.0-4.0 inr.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; mannheim (baden-wurttemberg), 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 9384268
• MDR Text Key: 197782210
• Report Number: 1823260-2019-90263
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 07671679190
• Device Lot Number: 314047
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR