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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 Problems Inaccurate Delivery (2339); High Test Results (2457)
Patient Problems Hyperglycemia (1905); Nausea (1970); Blurred Vision (2137); Dizziness (2194); Polydipsia (2604)
Event Type  Injury  
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.
 
Event Description
On (b)(6) 2016 the reporter contacted animas alleging that on an unspecified date, the patient experienced elevated blood glucose (bg) up to 350mg/dl with blurred vision, nausea, thirst, and light headedness. Reportedly, the patient did not receive any treatment above and beyond the usual routine of diabetes care and management and remained on the pump. The reporter stated that the patient was under increased stress but was unwilling to rule out the pump; the reporter alleged that the patient did not feel the pump was delivering insulin accurately. The reporter noted that the patient's uncle had died, the patient's aunt was on life support, and the patient's spouse was in the emergency room. Additionally, the reporter noted that the patient had a history of multiple previous strokes. This complaint is being reported based on the allegation that the patient experienced hyperglycemia associated with alleged insulin delivery issue.
 
Manufacturer Narrative
Follow-up #1: date of submission 07/12/2006. Device evaluation: the device has been returned and evaluated by product analysis on 06/29/2016 with the following findings: a review of the black box indicated that the last basal and last bolus deliveries occurred on (b)(6) 2016. The black box showed an occlusion alarm at 23:53 on (b)(6) 2016 and deliveries resumed on (b)(6) 2016 at 05:43. 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 errors, alarms, or warnings occurring. A 10 unit audio bolus and a 10 unit normal bolus were successfully completed with no issues. The pump passed delivery accuracy testing and was found to be delivering within required specifications. The complaint could not be confirmed or duplicated on investigation. 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 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 Key5737728
MDR Text Key47824879
Report Number2531779-2016-12480
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 05/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610008221288182316
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age10 MO
Event Location No Information
Date Manufacturer Received05/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/28/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/21/2016 Patient Sequence Number: 1
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