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

Device Problem Moisture Damage (1405)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The pump has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.

Event Description

On (b)(6) 2015 the reporter contacted animas, alleging a casing moisture ingress issue.There was no indication that the device caused or contributed to an adverse event.This complaint is being reported because the reported issue was not resolved with troubleshooting.

Manufacturer Narrative

Follow-up # 1: device evaluation: the pump has been returned and evaluated by product analysis on 09/01/2015 with the following findings: the pump was returned and it was noted that there was moisture ingress present in the battery compartment.A leak test was performed and it was confirmed that there was a battery compartment leak due to a crack along the side of the compartment.The pump case was opened and no evidence of moisture was found inside.

• 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: 4946334
• MDR Text Key: 23014658
• Report Number: 2531779-2015-25806
• 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
• Report Date: 07/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 20 MO
• Date Manufacturer Received: 07/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2013
• 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 Age: 16 YR
• Patient Weight: 92