FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3903893 · Received June 30, 2014

Report

Report Number: 2531779-2014-18678
Event Type: Malfunction
Date Received: June 30, 2014
Report Date: June 25, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1 DATE OF SUBMISSION 08/06/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: DURING A VISUAL INSPECTION OF THE PUMP, MOISTURE WAS OBSERVED BEHIND THE DISPLAY LENS. EVIDENCE OF MOISTURE INGRESS WAS ALSO FOUND ON THE UNDERSIDE OF THE BATTERY CAP, AND THE PUMP CASING WAS CRACKED NEAR THE UPPER RIGHT CORNER OF THE DISPLAY. A LEAK TEST WAS PERFORMED AND CONFIRMED A LEAK AT THE CRACK IN THE PUMP CASING. THE PUMP CASE WAS REMOVED AND FURTHER EVIDENCE OF MOISTURE INGRESS WAS FOUND. FURTHER TESTING COULD NOT BE COMPLETED; THE PUMP WAS UNRESPONSIVE DUE TO MOISTURE DAMAGE.

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 CASING/CONDITION (MOISTURE INGRESS) ISSUE. IT WAS REPORTED THAT MOISTURE WAS VISIBLE BEHIND THE PUMP DISPLAY LENS. 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
380168	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	14 YR