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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 Crack (1135); Device Stops Intermittently (1599)
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 that the pump intermittently lost power.It was also reported that the battery compartment was cracked, the battery cap threads were stripped, and the battery cap could not be secured properly to the pump.There was no indication that the product caused or contributed to an adverse event, and the reported issue was not resolved with troubleshooting.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 09/06/2016-device evaluation: the pump was returned and evaluated by product analysis on 08/09/2016 with the following findings: a review of the pump black box data revealed several pump reboots.During a visual inspection of the pump, the battery compartment was observed to be cracked in two places and the battery cap threads were found to be stripped.The battery cap did not secure properly to the pump; the complaint of no power was duplicated.The battery cap contact height also did not measure within specifications.A test cap secured properly to the pump to maintain power.The pump case was removed and no intermittent conditions were found to the printed circuit board.
 
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Brand Name
ANIMAS VIBE
Type of Device
INSULIN 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 Key5802370
MDR Text Key50461361
Report Number2531779-2016-16507
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 06/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Other Device ID Number011084040610005121246811616
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age15 MO
Initial Date Manufacturer Received 06/28/2016
Initial Date FDA Received07/18/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age29 YR
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