ACCU-CHEK SPIRIT COMBO

Additional Manufacturer Narrative

PRODUCT RECEIVED ON (B)(4) 2013. THE INSULIN PUMPS ELECTRONIC COMPARTMENT HAS BEEN VISUALLY INSPECTED. THE ACID OF THE SUPERCAP HAS LEAKED OUT AS A RESULT OF A MANUFACTURING ERROR. THEREFORE THE SUPERCAP AND THE SURROUNDING ELECTRONIC PARTS ARE CORRODED. THIS LED TO A HIGHER POWER CONSUMPTION OF THE PUMP. THE HIGH POWER CONSUMPTION LED TO A QUICK VOLTAGE DROP, THEREFORE, THE W2 ERROR MESSAGE WAS ANTICIPATED. A SUPERCAP IS A CAPACITOR FOR SAVING THE DATE AND TIME FOR A WHILE, WHEN NO BATTERY IS IN THE PUMP.

Description of Event or Problem

PATIENT REPORTED A BLOOD GLUCOSE LEVEL ON (B)(6) 2013 AROUND 11 PM OF 79 MG/DL; PATIENT ATE. PATIENT STATED ON (B)(6) 2013 AT 12 AM THE INFUSION DEVICE SWITCHED OFF UNEXPECTEDLY WITHOUT ANY ERROR OR ALARM MESSAGE. PATIENT REPORTED THE INFUSION DEVICE WAS MISSING THE W2 (LOW BATTERY) AND THE E2 (BATTERY DEPLETED) ERROR MESSAGES. PATIENT STATED THE LAST BATTERY CHANGE WAS IN (B)(6) 2012. PATIENT STATED AT 6 AM WHEN HE WOKE UP HE NOTICED THAT THE INFUSION DEVICE WAS TURNED OFF AND THEN PLACED A NEW BATTERY IN THE DEVICE. PATIENT REPORTED HE READ OUT THE INFUSION DEVICE WITH A 360 DEGREE VERSION 2.0 AND NOTICED THAT THE DEVICE SWITCHED OFF AT 12 AM. PATIENT STATED HIS BLOOD GLUCOSE LEVEL WAS 204 MG/DL. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PATIENT REPORTED HE CHANGED THE INFUSION SET AND AT 10 AM HIS BLOOD GLUCOSE LEVEL WAS 359 MG/DL. PATIENT STATED AT 1 PM HIS BLOOD GLUCOSE LEVEL WAS 128 MG/DL; NO MEDICAL CARE WAS NEEDED. 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.