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

Device Problems Loss of Power (1475); Failure to Prime (1492); Device Displays Incorrect Message (2591); Battery Problem (2885)

Patient Problems Death (1802); Hyperglycemia (1905); Loss of consciousness (2418)

Event Type  Death  

Event Description

The reporter (medical examiner) contacted animas on (b)(6) 2015 stating that the patient passed away on (b)(6) 2015.The reporter was contacting animas to obtain available information about the pump.Emergency medical services (ems) was contacted on (b)(6) 2015 when the patient was found unresponsive.The patient was taken to the hospital on (b)(6) 2015.The medical examiner was unable to find an actual admitting diagnosis, but stated there was information that the blood glucose (bg) was 300mg/dl and ¿wet pump.¿ there was no additional bg information available at the time of the call.Medical examiner believes the patient was still wearing the pump at the time of death but was uncertain.Based on the pump history, it appeared that the pump was without power as of (b)(6) 2015 and therefore not in use at the time of the patient¿s death.The prime history indicated that the last cart/site/set change was (b)(6) 2015.The total daily dose (tdd) history indicated a bolus delivery on (b)(6) 2015 but no bolus delivery on (b)(6) 2015.The alarm history shows a replace battery alarm at 11:41pm on (b)(6) 2015 followed by a low cartridge warning 1:47am on (b)(6) 2015.The previous record showed an empty cart alarm on (b)(6) 2015 at 11:47pm.There were no other remarkable alarms in history.Note there was no low battery warning prior to the replace battery alarm, but suspect low cartridge warning was not confirmed as the patient was already in the hospital at that time and bolus history indicates there was no user intervention with pump on (b)(6) 2015.This complaint is being reported because it was uncertain if the patient was wearing the pump at the time of death and because the pump could not be ruled out as a cause or contributor in the patient¿s death.

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.

Manufacturer Narrative

The insulin infusion pump was returned and investigated on 4/2/2015.No activity outside of normal use was observed in the black box or downloaded pump history.The pump was able to complete the rewind, load, and prime sequence without difficulty.A normal 10 unit bolus was performed and all units were delivered and recorded in the history.The basal program was set to 1.00 unit per hour and was executed for 24 hours.The daily insulin delivery totals correctly reflected the user's programmed basal rates.The pump passed delivery accuracy tests and was found to be delivering within required range and delivering accurately.

Manufacturer Narrative

Follow-up #1 date of submission 03/30/2015 - device evaluation: the cartridge has been returned and evaluated by product analysis on (b)(4) 2015 with the following findings: evaluation revealed that the cartridge passed visual inspection with no damage or defects noted.A fill test was completed with no air bubbles being formed inside the cartridge.A leak test was performed with no failures being observed; no leaks were observed from the luer connection, o-rings, or anywhere else in the cartridge.There was no defect found.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 342
• Manufacturer (Section G): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 342
• Manufacturer Contact: karin sargrad ; 200 lawrence dr; west chester, PA 19380-3428 ; 4843561808
• MDR Report Key: 4572825
• MDR Text Key: 5474988
• Report Number: 2531779-2015-07534
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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 Manufacturer: 03/12/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 20 MO
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 03/05/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/30/2015; 04/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2013
• 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
• Patient Outcome(s): Death
• Patient Age: 20 YR
• Patient Weight: 45