FDA Adverse Event Malfunction Summary report: N

ANIMAS INSULIN INFUSION PUMP

MDR report key: 2772344 · Received October 4, 2012

Report

Report Number: 2531779-2012-11564
Event Type: Malfunction
Date Received: October 4, 2012
Report Date: September 18, 2012
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K042873
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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.

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 2012- DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE FULLY INTACT; NO PEELING OR DAMAGE WAS OBSERVED. DURING TESTING, THE DOWN ARROW AND CONTRAST BUTTONS WERE INTERMITTENTLY UNRESPONSIVE; ALL OTHER BUTTONS RESPONDED APPROPRIATELY. DURING INVESTIGATION, EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS.

Description of Event or Problem · 1

THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 STATING THAT THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE PATIENT DENIED ANY DAMAGE TO THE KEYPAD OR EVIDENCE OF MOISTURE IN THE PUMP. THE PATIENT REPORTEDLY WORE THE PUMP IN A POCKET AND DID NOT CLEAN THE PUMP. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGED KEYPAD ISSUES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANIMAS INSULIN INFUSION PUMP	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION	ANM 2020 INSULIN INFUSION PUMP

Patients

Seq	Age	Sex	Outcome	Treatment
1