MAUDE Adverse Event Report: ANIMAS CORPORATION ONETOUCHPING GLUCOSEMGMTSYSTEM; INSULIN INFUSION PUMP

Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
On (b)(6) 2017, the reporter contacted animas, alleging a prime (loss of prime) issue.There was no indication that the device caused or contributed to an adverse event.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.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 05/16/2017 with the following findings: review of the black box data revealed one loss of prime warning (162) recorded on (b)(6) 2017 and associated with a cartridge change.On investigation, the pump was exercised for 24 hours without loss of prime duplicated.Force calibration was evaluated and found to be within required specifications.Investigation did not duplicate the complaint.Unrelated to the original complaint, the battery compartment was noted to be cracked.(b)(4).

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 6510121
• Report Number: 2531779-2017-08217
• Device Sequence Number: 13863490
• Product Code: LZG
• UDI-Device Identifier: 10840406100839
• UDI-Public: 0110840406100839
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2017

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 YR