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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 Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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) 2016, the reporter contacted animas, alleging a power (battery life w/ damage) issue.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.
 
Manufacturer Narrative
Follow-up #1: date of submission 09/29/2016 device evaluation: the device has been returned and evaluated by product analysis on 09/02/2016 with the following findings: black box shows evidence of short battery life on (b)(6) 2016 with drastic 21 counts voltage drop leading to ¿cs128¿ alarm.The battery compartment is cracked at threads on the side; returned battery cap is undamaged and able to fit.Moisture corrosion is observed in the battery canister and on the battery cap, leak test failed due a battery compartment leak.3-¿ez-prime¿ steps were performed correctly; all currents draw are within spec (step30).Unable to duplicate reported ¿short battery life¿ complaint.The pump¿s cover was removed, further moisture corrosion was found to the cgm module.The display lens is cracked along the bottom gray contour.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.(b)(4).
 
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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 Key5812421
MDR Text Key50919029
Report Number2531779-2016-17021
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
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 Patient
Type of Report Initial,Followup
Report Date 07/03/2016
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? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age30 MO
Date Manufacturer Received07/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2014
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 Age32 YR
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