FDA Adverse Event Malfunction Summary report: N

INRATIO2 PT/INR TEST STRIP

MDR report key: 5492158 · Received March 10, 2016

Report

Report Number: 2027969-2016-00155
Event Type: Malfunction
Date Received: March 10, 2016
Date of Event: February 22, 2016
Report Date: February 26, 2016
Manufacturer: ALERE SAN DIEGO, INC.
Product Code: GJS
PMA / PMN Number: K110212
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE TESTING HISTORY FOR THE REPORTED LOT WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT K370018 MET RELEASE CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. A ROOT CAUSE COULD NOT BE DETERMINED BY THE INFORMATION PROVIDED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

Description of Event or Problem · 1

ALERE'S (B)(4) AFFILIATE WAS NOTIFIED BY A PATIENT WHO REPORTED A VARIANCE BETWEEN THE INRATIO2 INR RESULT AND AN INR RESULT THAT WAS OBTAINED AT THE PHYSICIAN'S OFFICE. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2016, INRATIO2 INR: 2.1, PHYSICIAN OFFICE INR: N/A; (B)(6) 2016, N/A, 1.4. THERAPEUTIC RANGE: UNKNOWN. IT IS UNKNOWN IF THE PHYSICIAN'S OFFICE INR WAS A POINT OF CARE (POC) DEVICE OR A LABORATORY DRAW. THE PATIENT WAS UNABLE TO PROVIDE ANY FURTHER DETAILS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO ADDITIONAL INFORMATION WAS PROVIDED. (NOTE: THIS MDR FILING IS DUE TO THE DEVICE BEING THE SAME OR SIMILAR AS A DEVICE AVAILABLE IN THE UNITED STATES.)

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
147587	INRATIO2 PT/INR TEST STRIP	PROTHROMBIN TIME TEST	GJS	ALERE SAN DIEGO, INC.	99008G1	K370018

Patients

Seq	Age	Sex	Outcome	Treatment
1