FDA Adverse Event Injury Summary report: N

ACCU-CHEK SPIRIT

MDR report key: 1780791 · Received July 27, 2010

Report

Report Number
2183996-2010-01473
Event Type
Injury
Date Received
July 27, 2010
Date of Event
June 26, 2010
Report Date
June 28, 2010
Manufacturer
ROCHE INSULIN DELIVERY SYSTEMS INC.
Product Code
LZG
PMA / PMN Number
K060876
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
UT, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

ON (B)(6)2010, NURSE REPORTED PT WAS HOSPITALIZED ON (B)(6)2010 FOR KETOACIDOSIS. TROUBLESHOOTING WAS INITIATED WITH NURSE, AND IT WAS FOUND THE INSULIN CARTRIDGE WAS EMPTY. NURSE REPORTS THERE WAS CONDENSATION IN INSULIN CARTRIDGE AND THE INFUSION DEVICE VOLUME INDICATOR DISPLAYED 199 UNITS REMAINING IN INSULIN CARTRIDGE. INSULIN CARTRIDGE WAS REMOVED, AND THE CHAMBER OF THE INFUSION DEVICE WAS DRY BUT SMELLED OF INSULIN. PT'S DAUGHTER PROVIDED ADDITIONAL DETAILS REGARDING THE EVENT. DAUGHTER REPORTS PT WAS ADMITTED TO HOSPITAL ON (B)(6)2010 AT 2:30 WITH AN ELEVATED BLOOD GLUCOSE OF 483 MG/DL. AT 4 P.M., BLOOD GLUCOSE WAS 668 MG/DL. TARGET BLOOD GLUCOSE IS 140-160 MG/DL. BLOOD GLUCOSE WAS ELEVATED FOR TWO DAYS PRIOR TO HOSPITALIZATION. DAUGHTER IS CERTAIN THAT THE INSULIN CARTRIDGE WAS NOT EMPTY UPON INSERTION. INSULIN CARTRIDGE WAS INSERTED ON THE MORNING OF (B)(6)2010, WHICH IS THE SAME DAY BLOOD GLUCOSE ELEVATED. NO ALERTS OR ERRORS WERE RECEIVED ON THE INFUSION DEVICE, AND TIME AND BASAL RATES WERE PROGRAMMED CORRECTLY. PT DID NOT FORGOT TO DELIVER MEAL BOLUSES; THERE WERE NO RECENT CHANGES TO MEDICATIONS. INSULIN WAS NOT EXPIRED, AND THERE WERE NO AIR BUBBLES OR LEAKING IN THE SYSTEM. INFUSION SITE HAD NOT BEEN DISLODGED OR DISCONNECTED. INFUSION DEVICE WAS NOT DROPPED, CRACKED OR EXPOSED TO WATER OR OTHER LIQUIDS. BLOOD GLUCOSE HAS SINCE STABILIZED. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION.

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 62 YR Hospitalization| R INFUSION SET| INSULIN