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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 Failure to Prime (1492)
Patient Problems Hypoglycemia (1912); Sweating (2444)
Event Type  Injury  
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 patient contacted animas, alleging a prime (loss of prime) issue. The patient stated that they had a blood glucose (bg) 36mg/dl with sweating. The patient stated that they self-treated with a glucagon injection. Customer support (cs) completed troubleshooting and cs advised the patient to not continue to fill cannula while attached as this stop is not required for the pump to lose its prime. This report is being made due to the bg excursion the patient experienced due to a prime issue.
 
Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 11/10/2016 with the following findings: the black box shows loss of prime warning associated with low non-zero force leading to delivery interruptions. An ezprime and a 24hr duration test were successfully completed with no loss of prime warnings being duplicated. The pump is detecting the correct force. 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; force sensor pins seated and solder connections intact. No evidence of contamination or cracked force sensor traces. No evidence of internal moisture was found. Unidentified force low observed in the black box, force sensor calibration in specifications. 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 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 Key5947085
MDR Text Key54582931
Report Number2531779-2016-25100
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 08/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2016
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 Manufacturer11/03/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age7 MO
Event Location No Information
Date Manufacturer Received08/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/04/2016
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: 09/13/2016 Patient Sequence Number: 1
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