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 04/06/2015 ¿ device evaluation: the pump has been returned and evaluated by product analysis on (b)(6) 2015 with the following findings: a review of the pump¿s black box history showed that a loss of prime warning due to low (non-zero) force was recorded.During testing, the pump performed the rewind, load, and prime steps with no alarms occurring.The pump was exercised for 24 hours on a 1 unit per hour basal rate with no alarms occurring.The force sensor calibration reading was found to be within the required specifications.The pump case was removed and no defects were found to the force sensor pins or solder connections.There was no evidence of cracked force sensor traces observed.Unrelated to the complaint, evaluation revealed that the display screen was dim and discolored.Also unrelated to the complaint, evaluation revealed that the battery compartment was cracked at the threads along the side.The complaint that the pump was emitting loss of prime warnings was observed in the pump history but was not able to be duplicated during investigation.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.

Event Description

On (b)(6) 2015, the reporter contacted animas, alleging a prime (loss of prime) issue.It was reported that the pump was emitting multiple loss of prime warnings.It was noted that the loss of prime occurred with at least three cartridges from two separate boxes within a 30 day period.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: 10489685
• MDR Text Key: 206166578
• Report Number: 2531779-2020-00160
• 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: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• 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: 02/19/2015
• Was the Report Sent to FDA?: Yes
• Device Age: 26 MO
• Date Manufacturer Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 50 YR
• Patient Weight: 73