UNISTRIP 1

Additional Manufacturer Narrative

NOTIFICATION: DUE TO PRODIGY ACCOUNT INADVERTENTLY NOT BEING MIGRATED FROM HTTPS://ESGTEST.FDA.GOV TO HTTPS://ESG.FDA.GOV, THIS REPORT WAS PREVIOUSLY SUBMITTED TO MDR TEST ENVIRONMENT. THIS IS A RE-SUBMISSION THROUGH HTTPS://ESG.FDA.GOV PRODUCTION WEBTRADER.

Description of Event or Problem

UNISTRIP RECEIVED A CALL ON (B)(6) 2015 REPORTING A MEDICAL INTERVENTION THAT OCCURRED (AT PRESENT EXACT DATE AND TIME IS UNKNOWN). PATIENT STATED THAT SHE WOKE UP AND PARAMEDICS WERE IN HER HOME INFORMING HER THAT HER BLOOD GLUCOSE WAS 30MG/DL WITH THE PARAMEDIC'S METER. HER STATEMENT INDICATING THAT SHE APPARENTLY PASSED OUT UNTIL BECOMING CONSCIENCE AGAIN WITH THE PARAMEDICS ON SITE. PATIENT'S BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 70MG/DL WITH THE UNISTRIP METER. UNISTRIP STAFF PROCEEDED WITH MEDICAL ATTENTION DIALOG BUT PATIENT DECLINED TO PROVIDE INFORMATION NEEDED TO COMPLETE THE DIALOG. NOTE: WITH THIS INITIAL SUBMISSION THIS REPORT WILL HAVE INFORMATION THAT IS MISSING IN DIFFERENT SECTIONS. UT IS REVIEWING CALL RECORDING TO COLLECT AS MUCH ADDITIONAL INFORMATION AS POSSIBLE. NOTE: THE UNISTRIP TEST STRIP INVOLVED IN THIS MEDICAL ATTENTION IS A GENERIC TEST STRIP THAT WORKS WITH SEVERAL MARKET GLUCOSE METERS. THE MARKET DEVICE IDENTIFIED IN THIS MEDICAL ATTENTION IS A ONE TOUCH ULTRAMINI GLUCOSE METER, SERIAL# (B)(4).

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3010622184-2015-00001 TO SUBMIT MANUFACTURER'S INVESTIGATION OF THE SUSPECT DEVICE. DEVICE WAS NOT RETURNED TO UNISTRIP BY PATIENT. UNISTRIP REQUESTED AN INTERNAL RECORD REVIEW FROM MANUFACTURER FOR THE DEVICE IN QUESTION. SEE RESULTS IN "FILE ATTACHMENTS" SECTION OF THIS REPORT. (B)(4).