FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3900409 · Received June 27, 2014

Report

Report Number: 2531779-2014-18570
Event Type: Malfunction
Date Received: June 27, 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: NC, US
Reporter Occupation: PATIENT

Narratives

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.

Additional Manufacturer Narrative · 1

FOLLOW-UP #2: DATE OF SUBMISSION 08/11/2014 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA DID NOT FIND ANY RELATED WARNINGS OR ALERTS. THE PUMP POWERED UP WITH THE VIBRATORY FEATURE BUT NO AUDIBLE ALARM. ALL THE BUTTONS FUNCTIONED PROPERLY. THE SOLDER ON THE AUDIO ASSEMBLY WAS FOUND TO HAVE CRACKED. UNRELATED TO THE AUDIBLE FEATURE ISSUE, THE DISPLAY WAS DIM AND DISCOLORED.

Description of Event or Problem · 1

ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A AUDIO TONE/VIBRATION (NO SOUNDS) ISSUE. REPORTEDLY, THE AUDIO FEATURE OF THE PUMP WAS NOT WORKING. THE REPORTER STATED THAT THERE WAS VIBRATORY FEATURE AND THE AUDIO SETTINGS WERE PROGRAMMED CORRECTLY. 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
377020	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR