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

Medical Device Problem Codes	Partial Blockage (1065); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Hyperglycemia (1905); Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device 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.(b)(4).
Event or Problem Description
On (b)(6) 2017, the reporter contacted animas and alleged the patient experienced a blood glucose greater than 250mg/dl but less than 500mg/dl with polyuria, polydipsia, and extreme drowsiness, associated with an alleged occlusion issue.During troubleshooting with customer technical support, it was revealed that the patient did not prime while attached following the occlusion alarm.The customer was unable/unwilling to troubleshoot insulin being pushed through the cartridge and the tubing.O this complaint is being reported based on the allegation that the patient experienced hyperglycemia associated with an occlusion issue.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 10/23/2017 with the following findings: a review of the black box showed occlusion alarms due to a high force leading to delivery interruptions.The pump was run for 24 hours and no occlusion alarms occurred.The force sensor measured the correct force.The total daily doses added up correctly and reflected the user's programmed basal rates.The pump passed delivery accuracy testing and no delivery defects were found.The pump was delivering with in the required range and delivering accurately.No alarms or delivery interruptions occurred during testing.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: 6837163
• Report Number: 2531779-2017-20148
• Device Sequence Number: 819731
• Product Code: OYC
• UDI-Device Identifier: 10840406100297
• UDI-Public: 0110840406100297
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/06/2017

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 08/06/2017
• Supplement Date Received by Manufacturer: 08/06/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 11/08/2017
• 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: 14 YR
• Patient Weight: 25