FDA Adverse Event Malfunction Summary report: N

INRATIO2 PT/INR TEST STRIPS

MDR report key: 5605879 · Received April 25, 2016

Report

Report Number: 2027969-2016-00247
Event Type: Malfunction
Date Received: April 25, 2016
Date of Event: April 4, 2016
Report Date: April 4, 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 IN-HOUSE TESTING HISTORY OF THE STRIP LOT WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT K380736 MET 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 FROM THE INFORMATION PROVIDED BY THE CUSTOMER. 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

ON (B)(6) 2016, A VARIANCE BETWEEN THE INRATIO2 INR RESULTS WAS REPORTED ON A PATIENT IN (B)(6). RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2016, INRATIO2 INR: 2.1, 1.3 AND 1.3 (TESTING PERFORMED CONSECUTIVELY). THERAPEUTIC RANGE: UNKNOWN. THE PATIENT STOPPED TAKING PHENPROCOUMON TEN (10) DAYS AGO AND WANTED TO RESUME ON THE DAY OF THE CALL. THE FIRST RESULT DID NOT SEEM PLAUSIBLE THEREFORE ADDITIONAL TESTING WAS PERFORMED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO ADDITIONAL INFORMATION WAS ABLE TO BE 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
259345	INRATIO2 PT/INR TEST STRIPS	PROTHROMBIN TIME TEST	GJS	ALERE SAN DIEGO, INC.	99008G1	K380736

Patients

Seq	Age	Sex	Outcome	Treatment
1