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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 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. 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. (b)(6).
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a power (intermittent power) issue. The reporter alleged that the pump would reboot intermittently. The reporter changed the battery; however, the ¿intermittent power¿ issue remained unresolved. It was reported that the battery compartment was damaged. No additional information was available. 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
Follow-up #1: date of submission 06/03/2016. Device evaluation: the device has been returned and evaluated by product analysis on 05/16/2016 with the following findings: the review of the black box data showed evidence of unexplained power reboots. The battery cap was not returned for investigation; therefore, all testing was performed with a test battery cap. The battery cap was unable to fully tighten and the intermittent power issue was duplicated. The battery compartment was cracked. Unrelated to the original complaint, evidence of moisture contamination was observed inside the battery compartment. A leak test was performed and failed due to a leak at the battery compartment crack. Upon removal of the pump case and pump disassembly, additional moisture was noted internally. 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. (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 Key5570547
MDR Text Key42995157
Report Number2531779-2016-07684
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 distributor,foreign
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 03/23/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age20 MO
Event Location No Information
Date Manufacturer Received03/23/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/29/2014
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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