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

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The pump 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.

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging a power (no power) issue.Reportedly, there were no damages to the battery cap or the battery compartment.Allegedly, there was no moisture in the pump.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.There was no indication that the product caused or contributed to an adverse event.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 06/23/2016 with the following findings: investigators were unable to adequately investigate and confirm the original complaint due to an additional failure; upon pump power up, a call service alarm 069 was reproduced and was unable to be cleared post-reboot attempt.The call service alarm 069 failure was defined as a language file corruption upon the language text retrieval and was recorded in the black box data as a call service alarm 87 failure.The investigators determined that the error is resident to u39 flash chip failure.The battery cap was returned with the pump and was able to secure to the pump and to a test pump.The pump was opened and no damages were observed to the power circuit.There was no evidence of internal moisture.Unrelated to the original complaint, the battery compartment was cracked.

• Brand Name: ANIMAS VIBE
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer (Section G): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer Contact: karin sargrad ; 200 lawrence dr; west chester, PA 19380-3428 ; 4843561808
• MDR Report Key: 5703027
• MDR Text Key: 46874555
• Report Number: 2531779-2016-11168
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 05/18/2016

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 17 MO
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 06/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1