MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE; INSULIN INFUSION PUMP

Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump 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 or Problem Description
On (b)(6) 2017, the reporter contacted animas stating that the patient¿s bg (blood glucose) will go into the high 200¿s mg/dl and will drop between the 140¿s-160 mg/dl with symptoms of dehydration associated with an alleged prime issue.Reportedly the patient resumed pump therapy after it was replaced.The patient received a low dose of insulin via injection and the patient¿s mother spoke with their health care provider over the phone.During troubleshooting with customer technical support, it was noted that the pump is on the prime/rewind screen, the boxes next to the prime and fill cannula were not shaded in but the pump was not alarming ¿loss of prime.¿ the reported bg excursion does not meet the criteria of a serious injury.This complaint is being reported because the issue may result in a long term cessation of insulin delivery if the user does not receive an alarm.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 11/10/2017 with the following findings: during investigation, the pump's total daily dosage history was reviewed and indicated that the pump delivered the programmed basal rates on the date of the reported malfunction.Total daily dose totals were found to match the basal rate, and no indication of delivery interruptions were observed.The pump was run on a basal program for a minimum of 24 hours with no loss of prime; prime, or cannula boxes not filled in.Investigation was unable to duplicate the original complaint.The pump passed a delivery accuracy test.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.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 6904050
• Report Number: 2531779-2017-22656
• Device Sequence Number: 108340
• Product Code: OYC
• UDI-Device Identifier: 10840406100617
• UDI-Public: 0110840406100617
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P130007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 12 MO
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 YR