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

Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Structural Problem (2506)
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 and evaluated by product analysis on 13-jul-2018 with the following findings: during investigation, the black box showed evidence of unexplained pump reboots leading to delivery interruptions.The battery compartment was found to be cracked.The returned battery cap had stripped threads and was unable to maintain electrical connection.A test battery cap was able to fit and maintain electrical connection and was used to complete a 24 hr duration test.There were no pump reboots duplicated during that time.The total daily dose added up correctly and reflected the users programmed basal rates.The pump passed delivery accuracy testing and was found to be delivering accurately and within range.There was no damage found to the power circuit.(b)(4).
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas alleging that the patient experienced a blood glucose of 400 mg/dl with polyuria, polydipsia, shortness of breath, strong fruity breath odor and symptoms of dehydration associated with an alleged power with damage issue.Reportedly, the patient discontinued pump therapy and did not receive any treatment above and beyond the usual routine of diabetes care and management.The patient did receive insulin via injection.During troubleshooting with customer technical support, it was noted that the bg was contributed to the power interruption that was associated with a cracked battery compartment.This complaint is being reported because the patient experienced hyperglycemia associated with an alleged power with damage issue.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7698219
• Report Number: 2531779-2018-13059
• Device Sequence Number: 19112604
• Product Code: OYC
• UDI-Device Identifier: 10840406100341
• UDI-Public: 10840406100341
• Combination Product (Y/N): Y
• Initial Reporter State: ID
• 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
• Report Date (Section B): 07/02/2018

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: 07/10/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 24 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 07/18/2018
• 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: 17 YR
• Patient Weight: 90