FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3930143 · Received July 11, 2014

Report

Report Number: 2531779-2014-19789
Event Type: Malfunction
Date Received: July 11, 2014
Report Date: July 5, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1 DATE OF SUBMISSION 09/10/2014-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. DURING TESTING, THE PUMP POWERED ON WITH APPROPRIATE AUDIBLE TONES; HOWEVER, THE DISPLAY SCREEN REMAINED BLANK AND NO VIBRATORY ALERTS WERE EMITTED. THE BLACK BOX DATA COULD NOT BE DOWNLOADED FOR REVIEW DUE TO MOISTURE DAMAGE. FURTHER ADEQUATE INVESTIGATION COULD NOT BE COMPLETED DUE TO ISSUES RELATED TO MOISTURE INGRESS.

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 CALL SERVICE ALARM (CS 052/053/054/055 SLEEP) ISSUE. IT WAS ALLEGED THAT THE ALARM HAD EMITTED THREE TIMES IN THE PAST THIRTY DAYS. 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
406087	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR