• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE INSULIN INFUSION PUMP

  • 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
 

ANIMAS CORPORATION ANIMAS VIBE INSULIN INFUSION PUMP Back to Search Results
Device Problems Crack (1135); Poor Quality Image (1408); Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the pump has been returned and evaluated by product analysis on 02/25/2016 with the following findings: investigation revealed a cracked battery compartment. The pump¿s cover was removed, intermittent condition was found to the cgm module due to a cold solder connection at the cgm inter-board gold pin. In addition, the display screen was dim and discolored. Unrelated to these issues, investigation revealed a communication issue between the pump and the cgm (continuous glucose monitoring) transmitter. The review of the black box data and the cgm history showed multiple call service alarms (cs215); however no cs215 alarms were duplicated during the actual investigation. A test transmitter was used and paired correctly with the pump. The pump and the test transmitter were tested overnight and no communication issues were duplicated. Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release. (b)(6). (b)(4).
 
Event Description
The pump was returned for investigation. Investigation revealed a cracked battery compartment. In addition, the display screen was dim and discolored. The pump's cover was removed, intermittent condition was found to the cgm module due to a cold solder connection at the cgm inter-board gold pin. This report is made based on results of investigation completed on 02/25/2016.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameANIMAS VIBE
Type of DeviceINSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
Manufacturer (Section G)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
Manufacturer Contact
karin sargrad
200 lawrence dr
west chester, PA 19380-3428
4843561808
MDR Report Key5490172
MDR Text Key40203455
Report Number2531779-2016-05521
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 02/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age36 MO
Event Location No Information
Date Manufacturer Received02/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-