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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hyperglycemia (1905)

Event Date 11/13/2013

Event Type  Death  

Event Description

The reporter contacted animas on (b)(6) 2014 inquiring if there was any way for the animas pump to communicate with ¿life line¿ or similar services during an emergency and if the pump can provide some insight on the time of death.The reporter was advised that the pump and meter remote were a closed system and communication is only between these 2 devices and requires user intervention.The reporter was also advised that the pump will not provide exact date of death but that pump history can show last use and any alarms that may have occurred.The reporter indicated that per the coroner the cause of death was related to high blood glucose; the only blood glucose level reported to animas related to this event was 800 mg/dl, however, it was not specified when this blood glucose occurred, who tested the blood glucose, and what methods were used to obtain this reading.The reporter indicated that the patient¿s reported time of death was on or near (b)(6) 2013, however, the patient¿s last contact was (b)(6) 2013.The reporter did not have a battery for the pump at the time of the call and was unable to review the pump history.The reporter was advised to call back to animas when a battery was available to review the pump history or arrange return of the pump for investigation.Animas has attempted to follow up with the reporter but has been unsuccessful at this time.This report is made based on the allegation that the patient¿s death was reportedly blood glucose related and the use of the insulin pump was unable to be ruled out as a possible cause or contributor of the patient¿s demise.

Manufacturer Narrative

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.

• 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: 4093240
• MDR Text Key: 17993809
• Report Number: 2531779-2014-26369
• 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: Patient
• Type of Report: Initial
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-MCBC-64
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 13 MO
• Date Manufacturer Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2013
• 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: 61 YR
• Patient Weight: 200