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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 Fail-Safe Did Not Operate (4046)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2023
Event Type  malfunction  
Event Description
It was reported that the infusion device shut off without first providing an error or alert message.
 
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.
 
Manufacturer Narrative
Correction - d4 catalog no and unique identifier were updated based on the returned product.
 
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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 DIABETES CARE GMBH
sandhoferstrasse 116
na
mannheim 68305
GM   68305
Manufacturer Contact
john krug
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key16695674
MDR Text Key312863799
Report Number3011393376-2023-00853
Device Sequence Number1
Product Code LZG
UDI-Device Identifier00401563880119
UDI-Public0401563880119
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number05027250001
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/04/2023
Initial Date FDA Received04/06/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Patient Sequence Number1
Patient Age49 YR
Patient SexMale
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