FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3840014 · Received May 29, 2014

Report

Report Number: 2531779-2014-15227
Event Type: Malfunction
Date Received: May 29, 2014
Report Date: May 21, 2014
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: OTHER

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

(B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE LAST BASAL DELIVERY AND THE LAST BOLUS WERE ON (B)(6) 2014. A MANUAL TIME/DATE CHANGE WAS OBSERVED IN THE BLACK BOX FROM (B)(6) 2014 11:19 TO (B)(6) 2014 11:19. THE ALARM HISTORY SHOWS ONLY TYPICAL USAGE ALARMS. THE BASAL AND BOLUSES ADD UP APPROPRIATELY TO TOTAL THE TDD. PUMP PASSED A DELIVERY ACCURACY TEST SUCCESSFULLY. THERE WAS NO DEFECT FOUND.

Description of Event or Problem · 1

ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (INACCURATE DELIVERY) 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
316720	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR