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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 Pumping Problem (3016)
Patient Problem Hyperglycemia (1905)
Event Date 12/26/2019
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
It was reported that patient experienced hyperglycemia due to recurring error messages; was hospitalized and treated with an iv of unknown content and corrections via alternative therapy.
 
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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
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim 68305
GM   68305
Manufacturer Contact
greg smith
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key9621210
MDR Text Key176042379
Report Number3011393376-2020-00260
Device Sequence Number1
Product Code LZG
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2020
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 Manufacturer01/30/2020
Is the Reporter a Health Professional? No
Date Manufacturer Received02/26/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage N
Patient Sequence Number1
Treatment
UNKNOWN INSULIN
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age27 YR
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