FDA Adverse Event Injury Summary report: N

ACCU-CHEK SPIRIT

MDR report key: 2151658 · Received June 28, 2011

Report

Report Number
2183996-2011-01950
Event Type
Injury
Date Received
June 28, 2011
Date of Event
May 30, 2011
Report Date
May 30, 2011
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
AL, US
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

ON (B)(6) 2011, MOTHER REPORTED THE BATTERY COVER WAS STUCK IN THE INFUSION DEVICE. AN A2 LOW BATTERY ALERT OCCURRED A FEW DAYS PRIOR, BUT THE BATTERY WAS NOT CHANGED. WHEN MOTHER ATTEMPTED TO CHANGE THE BATTERY, THE BATTERY TOOL BROKE. SHE TRIED A SECOND BATTERY TOOL, SCREWDRIVER, AND COINS AND WAS UNABLE TO REMOVE THE BATTERY COVER. MOTHER REPORTED PATIENT'S BLOOD GLUCOSE ELEVATED TO THE 500 MG/DL RANGE, AND NORMAL BLOOD GLUCOSE IS 150-200 MG/DL. MOTHER BELIEVES HYPERGLYCEMIA MIGHT BE RELATED TO THE LOW BATTERY. THE INFUSION SET AND CARTRIDGE WERE USED PER SPECIFICATION. MOTHER DISCONNECTED THE INFUSION SET FROM PATIENT'S BODY AND WAS ABLE TO SEE INSULIN DRIP FROM THE TUBING. MOTHER DELIVERED ADDITIONAL INSULIN, INCLUDING AN INJECTION, TO PATIENT BUT BLOOD GLUCOSE DID NOT DECREASE. MOTHER REPORTED SHE "KNOWS HOW TO TREAT DAUGHTER FOR THE HIGH BLOOD GLUCOSE." INFUSION DEVICE WAS NOT DROPPED, CRACKED, OR EXPOSED TO LIQUID. MOTHER REPORTED PATIENT WOULD SWITCH TO HER BACKUP INFUSION DEVICE. INFUSION DEVICE AND BATTERY COVER WERE REPLACED AND REQUESTED FOR EVALUATION. THREE ATTEMPTS WERE MADE TO FOLLOW-UP WITH MOTHER, AND THESE WERE UNSUCCESSFUL. IT IS UNKNOWN WHETHER PATIENT WOULD HAVE BEEN CAPABLE OF SELF-TREATMENT FOR HYPERGLYCEMIA.

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 7 YR Required Intervention INSULIN| INSULIN INFUSION SET