• 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 Problem Failure to Prime (1492)
Patient Problems Hyperglycemia (1905); Nausea (1970)
Event Type  Injury  
Manufacturer Narrative
The pump has not been returned to animas for evaluation. If the device is returned, an evaluation shall be completed and a supplemental report will be filed. The reason for the adverse event has been attributed to use error (patient not using the cartridge per its instructions for use).
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a prime (loss of prime) issue. The reporter stated that the patient had a blood glucose (bg) of 320mg/dl with nausea and moderate ketones. The patient did not receive any treatment above and beyond the usual routine care of diabetes management. Customer support (cs) completed troubleshooting and it was determined that the patient was not using the cartridge per ifu. This complaint is being reported because the patient allegedly experienced a bg excursion as a result of use error in not using the cartridge per its instructions for use.
 
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 Key6047658
MDR Text Key58075422
Report Number2531779-2016-29365
Device Sequence Number1
Product Code MDS
UDI-Device Identifier10840406100242
UDI-Public011084040610024221342779316
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 09/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Other Device ID Number1-MCBC-3762
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age0 MO
Event Location No Information
Date Manufacturer Received09/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/23/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/21/2016 Patient Sequence Number: 1
-
-