PTS PANELS GLUCOSE TEST STRIPS
Received Apr 9, 2013 · Event occurred Mar 8, 2013
Report 1836135-2013-00001 · MDR key 3049323
Device
Product problems
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE COMPLAINT WAS RECEIVED FROM (B)(6), WHERE THEY REPORTED UNDER-RECOVERY OF GLUCOSE LOT NUMBER U117 (EXP: 2013 05 08). THE CUSTOMER REPORTED COMPARATIVE DATA BETWEEN GLUCOSE TEST STRIPS LOT NUMBERS U117 AND U204 GLUCOSE RESULTS USING A CARDIOCHEK PA (CCPA). A TOTAL OF THREE TESTS WERE PERFORMED BY THE CUSTOMER WITH GLUCOSE LOT NUMBER U117 STRIPS AND ALL TESTS DEMONSTRATED LOWER THAN EXPECTED RESULTS. A TOTAL OF TWO TESTS WERE PERFORMED BY THE CUSTOMER WITH GLUCOSE LOT NUMBER U204 STRIPS AND ALL RESULTS WERE WITHIN THE ACCEPTABLE LIMITS. THE CUSTOMER RETURNED PRODUCT HAD NOT YET BEEN RETURNED AT THE TIME THIS PIR WAS WRITTEN. UNDER-RECOVERY WAS VERIFIED IN THE QC RETAINED STRIPS FOR GLUCOSE LOT NUMBER U117.