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

Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
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) 2016, the reporter contacted animas alleging that when the battery type of alkaline was confirmed on the verify screen, it reverted back to lithium and there were flashes of different colored lines across the screen.There was no allegation of an adverse event with this complaint.This complaint is being reported based on the allegation of a non-specific pump malfunction.
Additional Manufacturer Narrative
Follow-up #1 submitted on 12/9/2016: on (b)(6) 2016, the patient called back to report blood glucose excursions had occurred since pump use was stopped.On (b)(6) 2016, a malfunction related to the battery occurred and the reporter notified animas on (b)(6) 2016: the patient discontinued pump use.On (b)(6) 2016, the patient called again, reporting bg values ranging from the 600 mg/dl's to the low 40 mg/dl range in the six days he has been off the pump.This updated complaint is now being submitted to report the patient has experienced hyper- and hypoglycemia while on an alternate insulin delivery method due to the previously reported malfunction.
Additional Manufacturer Narrative
The pump has been returned to animas and evaluated on 01/13/2017 with the following findings: the black box showed an unexplained pump reboot event on (b)(6) 2016 at 14:40; deliveries never resumed.The last bolus delivery was a 5.55u normal bolus on (b)(6) 2016 at 13:56.The alarm history showed one low battery warning on the event date.The pump powered on to the verify screen with audible and vibratory features.The "battery type" on the verify screen was able to be manually switched from lithium to alkaline with no issues; no reverting back to lithium battery type was observed during the investigation.No flashes of different colored lines were duplicated on the display screen.No hypersensitive or stuck keys were observed on the keypad.The total daily doses added up correctly and reflected the user¿s programmed basal rates.The pump passed a delivery accuracy test with no delivery defects found.The pump was found to be delivering within the required range.No delivery interruptions or alarms occurred during testing.There was no evidence of internal moisture observed.

• 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: 6131581
• Report Number: 2531779-2016-32370
• Device Sequence Number: 18885025
• Product Code: LZG
• UDI-Device Identifier: 10840406101126
• UDI-Public: 0110840406101126
• 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,Followup
• Report Date (Section B): 11/05/2016

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
• Operator of Device: Lay User/Patient
• Other Device ID Number: 1-MCBC-64
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 29 MO
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/05/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/29/2016
• Supplement Report FDA Received Date: 12/09/2016; 02/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 205