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

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hypoglycemia (1912)

Event Date 01/02/2014

Event Type  Death  

Event Description

On (b)(6) 2014, a certified diabetes educator and a nurse practitioner reported to an animas territory manager that a patient had passed away.The health care providers indicated that the patient¿s death was related to complications from a hypoglycemic event; the reporters stated that they were unaware of any correlations with any insulin pump malfunctions or misuse but indicated that the patient was wearing the insulin pump at the time of the event.Animas has attempted to follow up with the patient¿s next of kin but has been unsuccessful at this time.This report is made based on the allegation that the patient passed away of complications due to a hypoglycemic event and the use of the insulin pump could not be ruled out as a possible cause or contributor to the event.

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: kelly stone ; 200 lawrence dr; west chester, PA 19380-3428 ; 4089564746
• MDR Report Key: 3665764
• MDR Text Key: 4318804
• Report Number: 2531779-2014-06231
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/06/2014

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
• Other Device ID Number: 1-MCBC-64
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 12 MO
• Initial Date Manufacturer Received: 02/06/2014
• Initial Date FDA Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2013
• 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: 52 YR
• Patient Weight: 245