MAUDE Adverse Event Report: ANIMAS LLC 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 device has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.
Event or Problem Description
On (b)(6) 2018, a reporter contacted animas alleging that a patient had experienced a hyperglycemic event while on the pump.The reporter stated that the patient had a blood glucose of 500 mg/dl with symptoms of nausea.The patient did not receive any treatment above and beyond the normal course of diabetes management.The reporter stated that the pump¿s time and date settings had switched am and pm, causing the pump¿s basal program to be offset of the expected deliveries.The reporter stated that the pump¿s time and date settings were resetting after the battery was removed.This complaint is being reported based on the allegation that the patient experienced a hyperglycemic event due to not verifying the pump¿s time and date settings as accurate when powering it on.The 3500a initial report submission with assigned medwatch report #: 2531779-2018-12100 and submission date of 02-jul-2018 was noted to remain as emdr status work in progress with fda status ack 2 of 3.An it ticket was opened by animas medical surveillance and animas it contacted the fda team on 06-jul-2018 with a request for the fda to accept this report through to status ack 3 of 3.Animas it services has confirmed to animas medical surveillance that after several follow up communications with the fda, the report remains at status ack 2 of 3.Since the report has not been accepted by the fda at this time, animas medical surveillance has drafted the initial medwatch report #: 2531779-2018-12100 and resubmitting the complaint to the fda on 26-jul-2018.
Additional Manufacturer Narrative
Follow-up #1: date of submission (b)(4) 2018.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 (b)(4) 2018 with the following findings: review of the black box data revealed that records from the date of the event were not available for review.The last basal delivery was on (b)(4) 2018.The last bolus delivery was a 20.90-unit-ez-carb normal bolus on (b)(4) 2018 at 11:56.The total daily dose history showed out-of-order dates from (b)(4) 2018 to (b)(4) 2018 to (b)(4) 2018.The black box data for these dates was not available.On investigation, the pump was exercised for 12 hours.After the 12-hour exercise, the battery was removed for 6 hours.The bench testing confirmed when the battery was reinserted after 6 hours without power, the time/date reset to the factory default setting.This issue is not likely to cause an adverse event because the pump displays the verify screen after it is rebooted and the time and date must be set to confirm the verify screen.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.Unrelated to the original complaint, the battery compartment was noted to be cracked during the investigation.

• 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: 7722434
• Report Number: 2531779-2018-13535
• Device Sequence Number: 13713275
• Product Code: OYC
• UDI-Device Identifier: 10840406103199
• UDI-Public: 10840406103199
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 06/17/2018

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?: No
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 12 MO
• Initial Date Received by Manufacturer: 06/17/2018
• Supplement Date Received by Manufacturer: 06/17/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 09/24/2018
• 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: 28 YR
• Patient Weight: 234