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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).
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Brand Name
Type of Device
Manufacturer (Section D)
200 lawrence dr
west chester PA 19380 3428
Manufacturer (Section G)
200 lawrence dr
west chester PA 19380 3428
Manufacturer Contact
karin sargrad
200 lawrence dr
west chester, PA 19380-3428
MDR Report Key5800084
MDR Text Key49750722
Report Number2531779-2016-16402
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
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 Received07/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age12 MO
Date Manufacturer Received06/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age22 YR
Patient Weight110