FDA Adverse Event Malfunction Summary report: N

COAGUCHEK ® XS SYSTEM

MDR report key: 5303249 · Received December 16, 2015

Report

Report Number: 1823260-2015-06054
Event Type: Malfunction
Date Received: December 16, 2015
Date of Event: December 1, 2015
Report Date: January 12, 2016
Manufacturer: ROCHE DIAGNOSTICS
Product Code: GJS
PMA / PMN Number: K062925
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER RETURNED ONE VIAL OF TEST STRIP LOT 203358 (VIAL # (B)(4) ) CONTAINING 12 TEST STRIPS. THE TEST STRIPS, VIAL AND STOPPER SHOWED NO NOTICEABLE DEFECTS. THE CUSTOMER'S STRIPS AND METER WERE TESTED AND COMPARED TO THE MASTER LOT STRIPS - 230734 VIAL # (B)(4). ALL OF THE INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE CUSTOMER'S ALLEGATION COULD NOT BE VERIFIED.

Description of Event or Problem · 1

THE CALLER REPORTED THAT THE RESULT OF 7.8 INR WAS OBTAINED ON THE PATIENT WITH A COAGUCHEK XS PLUS METER (SERIAL NUMBER (B)(4)) COMPARED TO THE LAB RESULT OF 2.9 INR. IT WAS REPORTED THAT THE FACILITY SENDS PATIENTS TO THE LAB FOR A COMPARISON TEST IF A RESULT OF GREATER THAN 4.9 INR IS OBTAINED ON THE METER. THE PATIENT DID NOT RECEIVE ANY TREATMENT BASED ON EITHER OF THE RESULTS. THE PATIENT IS NOT ON HEPARIN OR ANY DIRECT THROMBIN INHIBITORS. THE PATIENT DOES NOT HAVE ANY ANTIPHOSPHOLIPID ANTIBODIES. THE PATIENT'S THERAPEUTIC RANGE IS 2.0-3.0 INR. THE CUSTOMER FEELS FINE. THERE WAS NO ADVERSE EVENT. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED AND REPLACEMENT PRODUCT WAS SENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
831123	COAGUCHEK ® XS SYSTEM	PROTHROMBIN TIME TEST STRIPS	GJS	ROCHE DIAGNOSTICS	NA	20335812

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR			TOPROL XL