FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3760390 · Received April 21, 2014

Report

Report Number: 2531779-2014-10577
Event Type: Malfunction
Date Received: April 21, 2014
Report Date: March 26, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS FOUND TO HAVE MOISTURE VISIBLE THROUGH THE DISPLAY LENS. EVALUATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THERE WAS NO MOISTURE CORROSION VISIBLE INSIDE THE BATTERY COMPARTMENT. DURING TESTING, DISPLAY LENS LEAKS WERE FOUND. THE PUMP COVER WAS REMOVED AND MOISTURE CORROSION WAS VISIBLE ON INTERNAL COMPONENTS OF THE PUMP. UNRELATED TO THE COMPLAINT, THE DISPLAY LENS WAS OBSERVED TO BE SCRATCHED, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION.

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DAMAGED W/ MOISTURE) ISSUE. IT WAS REPORTED THAT THE DISPLAY LENS SEAL WAS PEELING. REPORTEDLY, THERE WAS MOISTURE BEHIND THE DISPLAY. 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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
240536	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	30 YR