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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 Problems Dehydration (1807); Hyperglycemia (1905); Urinary Frequency (2275); Diabetic Ketoacidosis (2364)
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 and alleged that the patient had a blood glucose of 363 mg/dl with moderate ketones, dehydration, and polyuria. Patient required no unusual treatment. During troubleshooting, the patient alleged that the pump had developed and intermittent power issue starting (b)(6) 2016. Customer support instructed the patient to try a new battery from a fresh pack, and the pump powered on appropriately. This complaint is being reported as the patient experienced hyperglycemia related to the power issue.
 
Manufacturer Narrative
Follow-up #1: date of submission 9/6/2016. Device evaluation: the device has been returned and evaluated by product analysis on 08/10/2016 with the following findings: the complaint was verified in the history but could not be duplicated during testing. Unexplained por observed in the black box on (b)(4) 2016 at 22:24. No damage found to battery compartment or returned battery cap. Returned battery cap was able to fully tighten to the pump with no yellow o ring showing. Pump was exercised for 24hrs with returned battery cap, no power interruptions were duplicated. The returned battery cap contact measurements are in specification. The tdd¿s add up correctly and reflect the users programmed basal rates. Pump passed delivery accuracy testing with no delivery defects found. Pump found to be delivering within required range and delivering accurately. Removed pump cover; no evidence of internal moisture or damage to the power circuit was found. 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 Key5812131
MDR Text Key50101954
Report Number2531779-2016-16988
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 06/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610003721179411016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age8 MO
Event Location No Information
Date Manufacturer Received06/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2015
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: 07/21/2016 Patient Sequence Number: 1
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