FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3834119 · Received May 27, 2014

Report

Report Number: 2531779-2014-14892
Event Type: Malfunction
Date Received: May 27, 2014
Report Date: May 16, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PATIENT

Narratives

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.

Additional Manufacturer Narrative · 1

FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2014. PRODUCT ANALYSIS: THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: INVESTIGATION COULD NOT BE COMPLETED DUE TO AN UNRELATED ISSUE. THE PUMP POWERED ON WITH A BLANK DISPLAY SCREEN THAT WAS OBSERVED TO BE CRACKED. THE DAMAGED DISPLAY SCREEN WAS REPLACED WITH A TEST DISPLAY, WHICH RETURNED THE PUMP¿S DISPLAY FUNCTIONALITY TO SPECIFICATION.

Description of Event or Problem · 1

ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DIM AND DISCOLORED DISPLAY SCREEN ISSUE. 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
310343	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	13 YR