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

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problems Fatigue (1849); Hyperglycemia (1905); Urinary Frequency (2275)

Event Type  Injury  

Manufacturer Narrative

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 pump has not been returned to animas. 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 Description

On (b)(6) 2016 the reporter contacted animas alleging that the patient experienced elevated blood glucose (bg) of 428mg/dl with excess urination and extreme drowsiness associated with a time/date reset issue. Reportedly, the patient did not receive any treatment above and beyond the usual routine of diabetes care and management and remained on the pump. The reporter alleged that the time and date reset to default settings when the battery was out of the pump for less than 24 hours. This complaint is being reported based on the allegation that the patient experienced hyperglycemia associated with a time/date reset issue, with use error as a contributing factor.

Manufacturer Narrative

Follow-up #1: date of submission 08/15/2016 device evaluation: the device has been returned and evaluated by product analysis on 07/19/2016 with the following findings: a review of the pump history indicated that the pump was running on default settings from (b)(6) 2016. The black box showed six ¿exceeds maximum total daily dose limit¿ warnings beginning (b)(6) 2007 22:13. A reboot was recorded at 22:37; when the pump was powered back on the time and date was set to 02:17 (b)(6) 2016 and deliveries resumed. A review of the total daily dose history indicated that insulin delivery totals correctly reflected programmed values. The pump successfully completed a rewind, load, and prime sequence. The pump was exercised for 24 hours with no issues occurring. The pump passed delivery accuracy testing and was found to be delivering within required specifications. Evaluation revealed the internal clock battery on the pcb had failed. The pump would not retain the user programmed date and time settings upon removal of the primary aa battery. When a new aa battery is inserted the pump displays the default date and time which must be manually confirmed (or reset) by the user in order to proceed. Unrelated to the original complaint, investigation revealed the following: the battery compartment was cracked in two places; the keypad cover was peeling at the ok keypad button, but all keypad buttons remained responsive. 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. (b)(4).

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• 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: 5800084
• MDR Text Key: 49750722
• Report Number: 2531779-2016-16402
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 12 MO
• Event Location: No Information
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 07/16/2016 Patient Sequence Number: 1