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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 Issue (2379)
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 history/settings (history/settings issue) issue.The reporter alleged the pump was not calculating the basal rates accurately.Troubleshooting completed by animas customer support revealed the basal history did not match the active basal program.It was reported that the patient experienced a blood glucose level of above 250 mg/dl but below 500 mg/dl, without any other symptoms of hyperglycemia.This incident does not meet animas's definition of an adverse event.This complaint is being reported because there is an allegation against the delivery function of the pump.
 
Manufacturer Narrative
Date of submission 07-jun-2018 the device has been returned and evaluated by product analysis on 30-may-2018 with the following findings: a review of the pump history showed the total daily doses added up correctly and reflected the programmed basal rate target.The battery cap was not returned and all testing was performed with a test battery cap.The rewind, load, and prime steps were performed successfully.The pump was run for 24 hours with a 1 unit per hour basal rate and at the end of testing the pump correctly reflected the expected 24 units.The pump performed within specifications and the alleged inaccurate delivery issue was unable to be duplicated during the investigation.Unrelated to the original complaint, the battery compartment was cracked at the threads on the side.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.
 
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Brand Name
ANIMAS VIBE
Type of Device
INSULIN 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 Key7443230
MDR Text Key105922451
Report Number2531779-2018-07700
Device Sequence Number1
Product Code OYC
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 03/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Other Device ID Number1-MCBC-3762
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2018
Was the Report Sent to FDA? Yes
Device Age24 MO
Initial Date Manufacturer Received 03/26/2018
Initial Date FDA Received04/19/2018
Supplement Dates Manufacturer Received03/26/2018
Supplement Dates FDA Received06/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/25/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age53 YR
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