ACCU-CHEK SPIRIT COMBO

Description of Event or Problem

PATIENT REPORTED GOING TO HER DIABETES COUNSELOR AND THE COUNSELOR ATTEMPTED TO PROGRAM A NEW BASAL RATE WITHOUT SUCCESS. PATIENT STATED THE INFUSION DEVICE DID NOT SAVE THE NEW SETTINGS AND THE ORIGINAL BASAL RATE SETTING WAS LOST. PATIENT REPORTED THE INFUSION DEVICE DID NOT DELIVER THE BOLUS SHE PROGRAMMED AND DISPLAYED DIFFERENT BOLUS VALUES. PATIENT STATED SHE THINKS THIS IS THE REASON FOR HER HYPOGLYCEMIA. NO BLOOD GLUCOSE VALUES WERE PROVIDED. PATIENT REPORTED SHE WAS ABLE TO GET HER HYPOGLYCEMIA UNDER CONTROL BY HERSELF. PATIENT'S NORMAL BLOOD GLUCOSE VALUE WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

Additional Manufacturer Narrative

THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. NO UNUSUALLY EVENTS COULD BE OBSERVED ON THE EVENT HISTORY OF THE PUMP. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.