Description of Event or Problem · 1
ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN ISSUE WITH THE ONE TOUCH ULTRALINK METER REVERTING TO SETUP MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT AN ALLEGED ISSUE BEGAN ON (B)(6) 2014 AT 8:00 A. M. THE PATIENT MANAGES HER DIABETES WITH INSULIN (UNKNOWN TYPE AND DOSAGE) AND STATED SHE HAD 26 UNITS OF INSULIN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT CLAIMED THAT SHE DID NOT DEVELOP ANY SYMPTOMS AND THERE WAS NO MENTION OF RECEIVING MEDICAL TREATMENT FOR A HIGH OR LOW BLOOD GLUCOSE EXCURSION. AT THE TIME OF TROUBLESHOOTING, THE CCA DOCUMENTED THAT THIS WAS NOT THE FIRST TIME THE PATIENT USED THE SUBJECT METER, AND THERE WAS NO MISUSE OF THE PRODUCT. THE CCA WALKED THE PATIENT THROUGH A RETEST AND THE ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING RULED-OUT AS REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION(S): THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. IN ADDITION, THERE IS NO EVIDENCE THE DEVICE MALFUNCTIONED. THIS COMPLAINT WAS INITIALLY RULED OUT BECAUSE THERE WAS NO INDICATION THAT THE PRODUCT MALFUNCTIONED DURING CUSTOMER SERVICE TROUBLESHOOTING AND THERE WAS ALSO NO ALLEGATION OF AN ADVERSE EVENT AS A RESULT OF THE REPORTED ISSUE. PA TESTING RESULTS OF THE RETURNED METER CHANGED THE CLASSIFICATION OF THE COMPLAINT TO A REPORTABLE MALFUNCTION. DEVICE EVALUATION. THE PATIENT¿S METER AND TEST STRIPS WERE RETURNED ON 9/9/2014. THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE BATTERY CONTACT CONTAMINATED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.