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

Device Problem Failure to Prime (1492)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.Follow-up #1: date of submission 04/03/2015 device evaluation: the device has been returned and evaluated by product analysis on (b)(6) 2015 with the following findings: loss of prime warnings were observed in the pump's black box where the force readings did not reach zero.The rewind, load cartridge, and prime steps were performed successfully with no alarms.A force sensor calibration test confirmed that the sensor was detecting the correct force.The pump was exercised for 24 hours with no loss of primes occurring.The pump was opened and no damage was found to the force sensor circuit.Unrelated to the initial allegation, the display screen was found to be dim and discolored.

Event Description

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

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer (Section G): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer Contact: jon mulberg ; 965 chesterbrook blvd; wayne, PA 19087
• MDR Report Key: 10488562
• MDR Text Key: 206167687
• Report Number: 2531779-2020-00159
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K080639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/19/2015
• Was the Report Sent to FDA?: Yes
• Device Age: 40 MO
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2011
• 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: 9 YR
• Patient Weight: 49