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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 Image Display Error/Artifact (1304); Moisture Damage (1405); Structural Problem (2506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the pump has been returned and evaluated by product analysis on 09/28/2016 with the following findings: investigation revealed the following: there was visible moisture corrosion in the battery compartment; the battery compartment was cracked in two places; leak testing revealed a battery compartment leak; the display was dim and discolored. Unrelated to these issues, investigation revealed a crack in the pump casing between the corner of the lens and the case seal. Additionally, evaluation revealed the internal clock battery on the pcb had failed. The pump would not retain the user programmed date and time settings upon removal of the primary aa battery. When a new aa battery is inserted the pump displays the default date and time which must be manually confirmed (or reset) by the user in order to proceed. (b)(6).
 
Event Description
The pump was returned for investigation. Investigation revealed moisture in the battery compartment, damage to the battery compartment, a battery compartment leak, and a dim display screen. This report is made based on results of investigation completed on 09/28/2016.
 
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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 Key6057390
MDR Text Key58510350
Report Number2531779-2016-29743
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 09/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number1-MCBC-3762
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age38 MO
Event Location No Information
Date Manufacturer Received09/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2013
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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