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

Medical Device Problem Codes	Premature Discharge of Battery (1057); Structural Problem (2506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump 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.No conclusions can be made at this time.
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas, alleging that the pump had shorter than expected battery life.This complaint is being reported because the issue may result in a long-term cessation of insulin delivery if the user is unable to resolve the alarm.There was no serious injury associated with the complaint.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 15-jun-2018 with the following findings: the black box showed partially discharged batteries were installed leading to replace battery alarms and low battery warnings.Unrelated to the original complaint the battery compartment was cracked above and below the bumper pad.The battery compartment threads were stripped.The battery cap was not returned for inspection.No moisture/corrosion was observed in the battery compartment.A test battery cap was able to attach to the pump and power it on.Current draws measured within specifications.The pump cover was; no evidence of moisture or loose components was found inside the pump.A "battery life" issue was not duplicated during testing.

• 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: 7266073
• Report Number: 2531779-2018-03306
• Device Sequence Number: 1655859
• Product Code: OYC
• UDI-Device Identifier: 10840406100372
• UDI-Public: 10840406100372
• Combination Product (Y/N): Y
• 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: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 06/06/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 15 MO
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 136