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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 Problems Premature Discharge of Battery (1057); Moisture Damage (1405)
Patient Problems Hyperglycemia (1905); Polydipsia (2604)
Event Type  malfunction  
Manufacturer Narrative
The pump has not been returned to animas at the time of this report. 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, a reporter contacted animas alleging that the pump had shorter than expected battery life and there was moisture behind the display. The reporter stated that the patient had a blood glucose of 350 mg/dl with symptoms of increased thirst. The alleged blood glucose excursion does not meet the criteria for an adverse event. The reporter stated that there was no physical damage observed with the pump. This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.
 
Manufacturer Narrative
Follow-up #1: date of submission 08/16/2016 device evaluation: the device has been returned and evaluated by product analysis on 07/27/2016 with the following findings: there were multiple low battery warnings and pump reboot events observed in the black box history. The pump's battery life was shorter than expected due to drawing a high current when idle. The pump experienced a pump reboot event during the investigation followed by a low battery alarm. There was evidence of moisture behind the display lens.
 
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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 Key5799550
MDR Text Key50322869
Report Number2531779-2016-16368
Device Sequence Number1
Product Code MDS
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,Followup
Report Date 06/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610004421855214916
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age16 MO
Event Location No Information
Date Manufacturer Received06/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2015
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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