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

Device Problem Failure to Read Input Signal (1581)

Patient Problem No Consequences Or Impact To Patient (2199)

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.Follow-up #3 date of submission 09/02/2015.Device evaluation: the pump has been returned and evaluated by product analysis on 08/11/2015 with the following findings: during a visual inspection of the pump, the keypad cover was observed to be torn at the contrast button.During testing, the up arrow and contrast keypad buttons were unresponsive; all other keypad buttons responded properly.The keypad cover was removed, and the up arrow and contrast button contacts were found to be inverted.Unrelated to the complaint, the cartridge cap was observed to be damaged.Follow-up #4 date of submission 09/03/2015-.Device evaluation: the pump has been returned and evaluated by product analysis on 08/11/2015 with the following findings: during a visual inspection of the pump, the keypad cover was observed to be torn at the contrast button.During testing, the up arrow and contrast keypad buttons were unresponsive; all other keypad buttons responded properly.The keypad cover was removed, and the up arrow and contrast button contacts were found to be inverted.Unrelated to the complaint, the cartridge cap was observed to be damaged.Follow-up #1 date of submission: 07/07/2015.Correction to device not evaluated code: 02 follow-up #2 date of submission 07/27/2015.Correction to mfr report #: this complaint was initially reported under report # 2531779-2015-22391.Report # 2531779-2015-22399 follow-up #3 is follow-up to the initial complaint documented under report # 2531779-2015-22391.

Event Description

On (b)(6) 2015, the reporter contacted animas, alleging a button/keypad (tactile change prior to damage) issue.It was also reported that the up arrow, down arrow and ok buttons were under responsive.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; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer (Section G): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer Contact: karin sargrad ; 200 lawrence dr; west chester, PA 19380-3428 ; 4843561808
• MDR Report Key: 10528027
• MDR Text Key: 206789447
• Report Number: 2531779-2020-00251
• 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: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• 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: 07/07/2015
• Was the Report Sent to FDA?: Yes
• Device Age: 32 MO
• Date Manufacturer Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2013
• 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: 11 YR