FDA Adverse Event Injury Summary report: N

ACCU-CHEK SPIRIT

MDR report key: 1905767 · Received November 16, 2010

Report

Report Number
2183996-2010-02357
Event Type
Injury
Date Received
November 16, 2010
Date of Event
November 6, 2010
Report Date
November 8, 2010
Manufacturer
ROCHE INSULIN DELIVERY SYSTEMS INC.
Product Code
LZG
PMA / PMN Number
K060876
Removal / Correction Number
NA
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
OH, US
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

ON (B)(6) 2010, PATIENT REPORTED ELEVATED BLOOD GLUCOSE OVER THE PREVIOUS 36 HOURS. BLOOD GLUCOSE ELEVATED TO "HI" AND WAS ABOVE 600 MG/DL. PATIENT CHANGED THE INFUSION SET AND INSULIN CARTRIDGE AND BOLUSED 6 UNITS OF INSULIN. BLOOD GLUCOSE REMAINED ELEVATED. PATIENT THEN GAVE AN INSULIN INJECTION, AND THIS LOWERED BLOOD GLUCOSE TO 196 MG/DL. PATIENT CHECKED BLOOD GLUCOSE A FEW HOURS LATER AND IT HAD ELEVATED TO 379 MG/DL. PATIENT BELIEVED THE INSULIN DELIVERY OF THE INFUSION DEVICE WAS TOO LOW. NO ERROR MESSAGES WERE RECEIVED ON INFUSION DEVICE. ADAPTER, INFUSION SET, INSULIN CARTRIDGE, AND BATTERY WERE USED PER SPECIFICATION. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO WATER. TIME, DATE, AND BASAL RATES WERE PROGRAMMED CORRECTLY. PATIENT DID NOT FORGET TO BOLUS. THERE WAS NO BLOOD OR LEAKING INSULIN IN THE SYSTEM. PATIENT DID NOT HAVE SCAR TISSUE OR BRUISING AT SITE LOCATION OR CHANGES TO HEALTH, MEDICATION, STRESS, OR EXERCISE. INFUSION DEVICE AND ADAPTER WERE REPLACED AND REQUESTED FOR EVALUATION. INSULIN CARTRIDGE AND INFUSION SET WERE DISCARDED. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. FOLLOW-UP WAS COMPLETED ON (B)(6) 2010. PATIENT REPORTED BLOOD GLUCOSE RETURNED TO NORMAL RANGE OF 130 MG/DL AFTER REPLACEMENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

Patients

Seq Age Sex Outcome Treatment
1 40 YR Required Intervention INSULIN INFUSION SET| INSULIN