FDA Adverse Event Malfunction Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3903926 · Received June 30, 2014

Report

Report Number: 2531779-2014-18683
Event Type: Malfunction
Date Received: June 30, 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: CA, 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 #1: DATE OF SUBMISSION (B)(4) 2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED. A REVIEW OF THE PUMP¿S BLACK BOX AND ALARM HISTORY REVEALED MULTIPLE ¿LOSS OF PRIME¿ WARNINGS DUE TO NON-ZERO FORCE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ¿LOSS OF PRIME WARNINGS¿ OR DUPLICATED ALARMS. THE FORCE SENSOR CALIBRATION WAS NOT WITHIN SPECIFICATIONS. THE PUMP WAS OPENED AND THE FORCE SENSOR RESISTANCE DID NOT MEASURE WITHIN SPECIFICATIONS.

Description of Event or Problem · 1

ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. IT WAS REPORTED THAT THE PUMP REPEATEDLY EMITTED LOSS OF PRIME WARNINGS DESPITE CARTRIDGE CHANGES. 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
380192	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	17 YR