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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK SPIRIT COMBO; INSULIN INFUSION PUMP
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ROCHE DIABETES CARE, INC. ACCU-CHEK SPIRIT COMBO; INSULIN INFUSION PUMP Back to Search Results
Catalog Number 05027250001
Device Problem Failure to Prime (1492)
Patient Problem Hyperglycemia (1905)
Event Date 09/01/2020
Event Type  Injury  
Manufacturer Narrative
The event occurred outside of the united states while this product is not sold in the united states, it is like or similar to a product marketed in the united states.
 
Event Description
The patient reports that during the cartridge change, the error message e11 (= infusion set not primed) was displayed by the infusion devise.The patient tried to change three complete infusion sets but the error message always appeared again.The following morning the patient went to the emergency room of the hospital with a blood glucose level of 600 mg/dl, was hospitalized, treated with insulin pens and was discharged on (b)(6) 2020.The hospital recommended changing to insulin injection via pen.
 
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Brand Name
ACCU-CHEK SPIRIT COMBO
Type of Device
INSULIN INFUSION PUMP
Manufacturer (Section D)
ROCHE DIABETES CARE, INC.
9115 hague road
indianapolis IN 46250 0457
MDR Report Key10521550
MDR Text Key206524301
Report Number3011393376-2020-03260
Device Sequence Number1
Product Code LZG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number05027250001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2020
Date Manufacturer Received10/13/2020
Patient Sequence Number1
Treatment
UNKNOWN INSULIN; UNKNOWN INSULIN
Patient Outcome(s) Hospitalization;
Patient Age56 YR
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