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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
Model Number ANIMAS VIBE INSULIN PUMP
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Hyperglycemia (1905); Nausea (1970)
Event Date 04/27/2012
Event Type  Injury  
Event Description
On (b)(6) 2012 the patient reported that the pump powered off while she slept overnight. The patient denied previous power issues. She said that the battery was original to the pump which she began to use one week ago. The patient reported that her blood glucose (bg) was 19mmol/l and stated that she felt nauseous and unwell. She stated that she powered up the pump with a new battery and delivered correction bolus via the pump. The patient inspected the pump and denied damage to the pump or battery cap. She claimed that the battery symbol showed a full charge on (b)(6) 2012. Review of the alarm history showed a replace battery alarm at 7:55am. The patient claimed that she did not hear the replace battery alarm. There was no allegation that the audible alarm system was not functional. Customer technical support assisted with changing the alarm setting to high as it was previously set to low. This complaint is being reported because the patient experienced a serious bg excursion due power loss after inadequate response to a replace battery alarm.
 
Manufacturer Narrative
The pump has not been requested for return to animas for evaluation at this time. Customer support concluded that use error caused the event and that there was no malfunction detected. 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. If the device is returned, an evaluation shall be completed and a supplemental report will be filed.
 
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Brand NameANIMAS VIBE
Type of DeviceINSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 342
Manufacturer (Section G)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 342
Manufacturer Contact
kelly stone
200 lawrence dr
west chester, PA 19380-3428
4089564746
MDR Report Key2587567
MDR Text Key2658702
Report Number2531779-2012-04503
Device Sequence Number1
Product Code LZG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Type of Report Initial,Followup
Report Date 04/27/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2012
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberANIMAS VIBE INSULIN PUMP
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received04/27/2012
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2011
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: 05/24/2012 Patient Sequence Number: 1
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