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U.S. Department of Health and Human Services

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

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ANIMAS CORPORATION ANIMAS VIBE INSULIN INFUSION PUMP Back to Search Results
Device Problem Moisture or Humidity Problem (2986)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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. No conclusions can be made at this time.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a power (damage with moisture ingress) issue. This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery. There was no indication that the product caused or contributed to an adverse event.
 
Manufacturer Narrative
Follow-up #1: date of submission 09/23/2016. 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. Device evaluation: the device has been returned and evaluated by product analysis on 08/30/2016 with the following findings: review of the black box data and pump history revealed multiple records of power on reset following manual time and date changes and/or pump not primed or replace battery alarms. The returned battery cap was able to secure properly to the pump. The pump was exercised for 24 hours without loss of power. Investigation did not duplicate a power issue. Damage and moisture was confirmed; the battery compartment was cracked and a piece of the case was missing. There was moisture inside the battery compartment. Leak testing confirmed moisture leakage due to the battery compartment crack. The pump was opened for further investigation and revealed moisture on the battery canister. Unrelated to the original complaint, the display was noted to be dim/faded and discolored.
 
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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 Key5845703
MDR Text Key52439077
Report Number2531779-2016-18795
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 consumer,foreign
Type of Report Initial,Followup
Report Date 07/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2016
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 Manufacturer08/17/2016
Was the Report Sent to FDA? Yes
Device Age31 MO
Event Location No Information
Date Manufacturer Received07/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/23/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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