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

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The pump has not been requested for return at this time.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) 2016 the reporter contacted animas alleging that on an unspecified date, the patient experienced elevated blood glucose (bg) over 500mg/dl.There were no reported signs or symptoms of hyperglycemia.Reportedly, the patient did not receive any treatment above and beyond the usual routine of diabetes care and management and remained on the pump.The reporter noted that the patient¿s healthcare provider had made basal rate changes associated with the alleged bg excursion.Customer technical support reviewed the pump with the reporter and found all settings and histories were correct; the pump was found to be delivering accurately as programmed.The reporter noted that the patient exhibited signs/symptoms of illness not caused by the bg excursion, and that the user had overridden bolus dosage recommendation(s) provided by the pump.The patient was referred to their healthcare provider for diabetes management.This complaint is being reported based on the allegation that the patient experienced hyperglycemia while using insulin pump therapy, with use error as a contributing factor.
Additional Manufacturer Narrative
Product analysis: the device was returned and evaluated by product analysis on 09/22/2017 with the following findings: review of the pump¿s black box indicated no abnormal pump behavior.Data relevant to the alleged event was overwritten due to extended pump use.The total daily dose history was appropriate for the user programmed delivery settings.The pump successfully completed a prime sequence, bolus deliveries, and 24-hour exercise test without issue or alarm.The pump passed a delivery accuracy test.The pump calculated boluses accurately.All deliveries performed during investigation were recorded accurately in the pump¿s history.

• 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: 6198749
• Report Number: 2531779-2016-34573
• Device Sequence Number: 18867411
• Product Code: OYC
• UDI-Device Identifier: 10840406100570
• UDI-Public: 0110840406100570
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2016

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?: No
• 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: 08/11/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: 12/08/2016
• Initial Report FDA Received Date: 12/22/2016
• Supplement Report FDA Received Date: 10/18/2017
• 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: Life Threatening
• Patient Age: 6 YR
• Patient Weight: 33