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

Medical Device Problem Codes	Partial Blockage (1065); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Hyperglycemia (1905); No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 14-aug-2018 with the following findings: during investigation, the black box showed twelve occlusion alarms with high force leading to delivery interruptions beginning on (b)(6) 2018.The last basal delivery occurred on (b)(6) 2018 due to occlusion alarm.The rewind, load cartridge, and prime steps performed successfully with no alarms.The pump was detecting correct force.The pump was exercised for 24 hours with no occlusions occurring.The total daily dose added up correctly and reflected the user's programmed basal rates.The pump passed delivery accuracy testing and was found to be delivering accurately and within range.The pump¿s cover was removed, and there was no intermittent condition found to the force sensor circuit.Lastly, the battery compartment was found to be cracked.
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas alleging that the patient experienced a blood glucose of 350 mg/dl with moderate ketones and nausea associated with an alleged occlusion issue.Reportedly, the patient discontinued pump therapy and did not receive any treatment above and beyond the usual routine of diabetes care and management but was given multiple manual injections to bring the blood glucose back down to the target range.During troubleshooting with customer technical support, it was noted there was an occlusion and a loss of prime.This complaint is being reported because the patient experienced hyperglycemia associated with an alleged occlusion issue.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 7822818
• Report Number: 2531779-2018-15511
• Device Sequence Number: 1351226
• Product Code: OYC
• UDI-Device Identifier: 10840406100280
• UDI-Public: 10840406100280
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2018

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: 08/10/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 20 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/28/2018
• 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: Life Threatening
• Patient Age: 13 YR