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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
Device Problem Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
On (b)(6) 2015, calibra received an anonymous survey indicating that the patch button was sometimes sticking.No additional information was provided related to the complaint.This complaint is being reported because the reported issue remained unresolved.There was no indication that the product caused or contributed to an adverse event.
 
Manufacturer Narrative
Calibra is unable to request the device for return at this time.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.
 
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Brand Name
FINESSE PATCH
Type of Device
FINESSE INSULIN DELIVERYSYSTEM
Manufacturer (Section D)
CALIBRA MEDICAL, INC
220 saginaw dr
redwood city CA 94063 472
Manufacturer (Section G)
CALIBRA MEDICAL, INC
220 saginaw dr
redwood city CA 94063 472
Manufacturer Contact
kelly stone
220 saginaw dr
redwood city, CA 94063-4725
4089564746
MDR Report Key4863561
MDR Text Key5863500
Report Number3008272700-2015-00005
Device Sequence Number1
Product Code OPP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111924
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 06/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received06/19/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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