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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 Battery Problem (2885)
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 a power (battery life) issue. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no indication that the product caused or contributed to an adverse event.
 
Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 3/30/2016 with the following findings: a review of the pump¿s black box data showed no evidence of a short battery life. A call service alarm (cs 128) was observed in the pump¿s history which occurred due to an unacknowledged cs 162 warning. The pump¿s ¿ez-prime¿ steps were performed correctly. All the current readings were within specification; the investigation was unable to duplicate the ¿short battery life¿ complaint. The product performed within specification. The pump¿s cover was removed and no intermittent condition was found to the power printed circuit board or to the cgm module. Unrelated to the initial complaint, it was observed that the battery compartment was cracked from the threads down to the case seal on the side of the pump. (b)(4).
 
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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 Key5487161
MDR Text Key40062846
Report Number2531779-2016-05460
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 03/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610005121355691016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age12 MO
Event Location No Information
Date Manufacturer Received03/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/11/2015
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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