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[IP] Pumps and MRIs - Death



There ARE reasons for "recommendations" re: insulin pumps:

MAUDE Database
BRAND NAMEANIMAS - R1000
TYPE OF DEVICE INSULIN PUMP FOR CSII
DEVICE EVENT KEY432850
MDR REPORT KEY443873
EVENT KEY420188
REPORT NUMBER443873
DEVICE SEQUENCE NUMBER1
PRODUCT CODELZG
REPORT SOURCEVOLUNTARY
REPORT DATE02/20/2003
1 DEVICE WAS INVOLVED IN THE EVENT
1 PATIENT WAS INVOLVED IN THE EVENT
DATE FDA RECEIVED02/21/2003
IS THIS AN ADVERSE EVENT REPORT?NO
IS THIS A PRODUCT PROBLEM REPORT?YES
DEVICE OPERATORLAY USER/PATIENT
WAS DEVICE AVAILABLE FOR EVALUATION?NO ANSWER PROVIDED
PATIENT OUTCOMEDEATH

ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION
REPORT DATE: 02/20/2003 MDR TEXT KEY: 1539876 Patient Sequence Number: 1
PT WAS AN INSULIN DEPENDENT TYPE I DIABETIC ON AN INSULIN PUMP - ANIMAS 
PUMP. FORGOT TO TAKE PUMP OFF WHEN IN MRI SCANNER. THAT EVENING PT HAD A 
MAJOR HYPOGLYCEMIC REACTION. SPOUSE RESCUED THE PT WITH GLUCAGON AND FED 
THEM A MEAL AND WENT TO BED. NEXT AM UNCONSCIOUS AND HYPOGLYCEMIC. PUMP WAS 
LATER FOUND TO BE DELIVERING 10 X NORMAL DOSE OF INSULIN.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=443873
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