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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 Inaccurate Delivery (2339)
Patient Problem No Consequences Or Impact To Patient (2199)
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) 2017, the reporter contacted animas, alleging that the pump did not deliver insulin accurately. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported because there is an allegation against the delivery function of the pump.
 
Manufacturer Narrative
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 02/25/2017 with the following findings: a review of the pump histories did not find any errors, alarms, or warnings associated with the complaint. A review of the total daily dose history indicated that insulin delivery totals correctly reflected programmed values. The pump successfully completed a rewind, load, and prime sequence. The pump was exercised for 24 hours with no issues occurring. The pump passed delivery accuracy testing and was found to be delivering within required specifications. No defects were found on investigation; the complaint could not be confirmed or duplicated.
 
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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 Key6318063
MDR Text Key67238536
Report Number2531779-2017-03295
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 01/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2017
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 Manufacturer02/15/2017
Was the Report Sent to FDA? Yes
Device Age1 MO
Event Location No Information
Date Manufacturer Received01/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2016
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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