FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3863806 · Received June 10, 2014

Report

Report Number: 2531779-2014-16331
Event Type: Malfunction
Date Received: June 10, 2014
Report Date: June 5, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ANALYSIS: THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/11/2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED WITH INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX REVEALED A LOSS OF PRIME ALARM. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. THE FORCE SENSOR WAS FOUND TO BE PROPERLY CALIBRATED. NO DAMAGE OR DEFECT WAS FOUND TO THE PUMP¿S INTERNAL COMPONENTS. 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.

Additional Manufacturer Narrative · 1

THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

Description of Event or Problem · 1

ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A LOSS OF PRIME ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED AND TROUBLESHOOTING COULD NOT BE PERFORMED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED. 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
341030	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	8 YR