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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 Hyperglycemia (1905)
Event Type  Injury  
Manufacturer Narrative
The device has been returned to animas. Evaluation has not yet been completed. When evaluation is complete a supplemental report will be filed. No conclusion can be made at this time.
 
Event Description
On (b)(6) 2016, the reporter contacted animas alleging the patient¿s blood glucose on an unknown date was 300 mg/dl with extreme thirst, nausea, and symptoms of dehydration. The reporter noted the patient did not receive any treatment above and beyond the usual routine of diabetes care and management, they remained on pump therapy, and the pump¿s basal settings were recently changed by a healthcare professional. During troubleshooting, it was reported that: the pump¿s basal history and total daily dose basal history were appropriate for the programmed basal rates; the bolus history matched the total daily dose bolus history; the pump was calculating recommended bolus totals correctly; the pump successfully delivered an air bolus, which was correctly recorded in the bolus history. After troubleshooting, an allegation remained that there were missing bolus records in the bolus history. This complaint is being reported because the reported health event was attributed to an alleged pump malfunction.
 
Manufacturer Narrative
Follow-up #1: date of submission 09/20/2016. Device evaluation: the device has been returned and evaluated by product analysis on 08/24/2016 with the following findings: a review of the bolus history showed that no boluses were programmed or delivery on (b)(6) 2016. 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. The pump passed delivery accuracy testing and was found to be delivering within required specifications. A 10unit normal bolus and a 10unit audio bolus were successfully performed and both were accurately recorded in the pump history. The bolus history was found to be recording properly. The keypad buttons were tested and no hypersensitivity was found. The complaint could not be confirmed or duplicated on investigation. Unrelated to the original complaint, investigation revealed that the battery compartment was cracked. 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 Key5883230
MDR Text Key52339236
Report Number2531779-2016-21477
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 07/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number1-MCBC-3762
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age17 MO
Event Location No Information
Date Manufacturer Received07/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/18/2015
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: 08/17/2016 Patient Sequence Number: 1
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