Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CALIBRA MEDICAL, INC FINESSE PATCH; FINESSE INSULIN DELIVERYSYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CALIBRA MEDICAL, INC FINESSE PATCH; FINESSE INSULIN DELIVERYSYSTEM Back to Search Results
Device Problems Sticking (1597); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Initial reporter: (b)(6).Calibra has been unable to request return of the product 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.
 
Event Description
On (b)(6) 2015, it was reported that a "change by" sticker came off the device which led to the patient missing a change of the device after 3 days.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the labeling did not alert the user to replace the patch.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FINESSE PATCH
Type of Device
FINESSE INSULIN DELIVERYSYSTEM
Manufacturer (Section D)
CALIBRA MEDICAL, INC
220 saginaw dr
redwood city CA 94063 4725
Manufacturer (Section G)
CALIBRA MEDICAL, INC
220 saginaw dr
redwood city CA 94063 4725
Manufacturer Contact
sam crawford
220 saginaw dr
redwood city, CA 94063-4725
6502984705
MDR Report Key5363024
MDR Text Key36271558
Report Number3008272700-2016-00002
Device Sequence Number0
Product Code OPP
PMA/PMN Number
K111924
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,study
Reporter Occupation Patient
Type of Report Initial
Report Date 12/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2016
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 Received12/29/2015
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
-
-