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

Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hyperglycemia (1905)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
On (b)(6) 2017, the reporter contacted animas and alleged that on (b)(6) 2017, the patient experienced a blood glucose over 600 mg/dl with abdominal pain and large ketones associated with intermittent power to the pump.Reportedly, the patient discontinued the insulin pump and was hospitalized and treated with insulin via injection and iv fluids.It was reported that there was no damage to the pump.This complaint is being reported because the patient allegedly experienced hyperglycemia due to an alleged intermittent power issue.
Additional Manufacturer Narrative
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.Device evaluation: the device has been returned and evaluated by product analysis on 01/09/2018 with the following findings: multiple unexplained power on reset records were in the black box between (b)(6) 2017.No meter was returned with the pump.No moisture/corrosion was observed in the battery compartment.No damage was found to battery compartment.A battery cap was not returned; a test battery cap fully attaches to the pump and was used to complete a 24hour duration test.No power interruptions were duplicated during this time.The total daily doses added up correctly to reflect the user¿s programmed basal rates.The pump passed delivery accuracy test and was found to be delivering accurately and within range.There was no evidence of internal moisture or damage to the power circuit.

• 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: 7103850
• Report Number: 2531779-2017-28000
• Device Sequence Number: 11080782
• Product Code: OYC
• UDI-Device Identifier: 10840406100365
• UDI-Public: 10840406100365
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 12/14/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 17 MO
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 15 YR