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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CALIBRA MEDICAL, INC FINESSE PATCH; FINESSE INSULIN DELIVERYSYSTEM
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CALIBRA MEDICAL, INC FINESSE PATCH; FINESSE INSULIN DELIVERYSYSTEM Back to Search Results
Lot Number 040
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device is not being returned.No conclusions can be made at this time.(b)(6).
 
Event Description
On 3/21/2017 it was reported that the buttons locked and the patient was not able to administer insulin dose for the meal.There was no indication that the product caused or contributed to an adverse event.The complaint is being reported because the alleged malfunction has the ability to result in a delay in treatment or long term cessation in delivery.
 
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Brand Name
FINESSE PATCH
Type of Device
FINESSE INSULIN DELIVERYSYSTEM
Manufacturer (Section D)
CALIBRA MEDICAL, INC
965 chesterbrook blvd
wayne PA 19087
Manufacturer (Section G)
CALIBRA MEDICAL, INC
965 chesterbrook blvd
wayne PA 19087
Manufacturer Contact
karin sargrad
965 chesterbrook blvd
wayne, PA 19087
4843561808
MDR Report Key6460551
MDR Text Key72178151
Report Number3008272700-2017-00009
Device Sequence Number1
Product Code OPP
Combination Product (y/n)N
PMA/PMN Number
K111924
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,study
Reporter Occupation Patient
Type of Report Initial
Report Date 03/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot Number040
Other Device ID Number1-2VSIX7R
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received03/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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