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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIMAS LLC ANIMAS VIBE INSULIN INFUSION PUMP

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ANIMAS LLC ANIMAS VIBE INSULIN INFUSION PUMP Back to Search Results
Device Problems Electrical /Electronic Property Problem (1198); Moisture Damage (1405); Structural Problem (2506)
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) 2018, the reporter contacted animas, alleging a power (damage with moisture ingress) issue. It was reported that the battery compartment was cracked wit moisture present. There was no allegation of an adverse event associated with this complaint. This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.
 
Manufacturer Narrative
Follow-up #1: date of submission (b)(4) 2018. 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 (b)(4) 2018 with the following findings: review of the black box data revealed records of unexplained power on reset events. Moisture corrosion was confirmed to be present i the battery compartment. The battery compartment was confirmed to be cracked. The returned battery cap had stripped threads and was unable to maintain electrical connection; with the damaged cap in place on the pump, the alleged power issue was duplicated. A test battery cap secured properly to the pump and was able to maintain electrical connection for a 12-hour duration test. No power interruptions occurred during the 12-hour test. There was no damage, defect or contamination of the pump¿s interior components.
 
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Brand NameANIMAS VIBE
Type of DeviceINSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS LLC
965 chesterbrook blvd
wayne PA 19087
Manufacturer (Section G)
ANIMAS LLC
965 chesterbrook blvd
wayne PA 19087
Manufacturer Contact
kristen lopolito
965 chesterbrook blvd
wayne, PA 19087
MDR Report Key7853996
MDR Text Key119706173
Report Number2531779-2018-16209
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/06/2018
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 Manufacturer09/12/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received08/22/2018
Was Device Evaluated by Manufacturer? Yes
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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