FDA Adverse Event Injury Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 3200621 · Received July 1, 2013

Report

Report Number: 2531779-2013-09437
Event Type: Injury
Date Received: July 1, 2013
Date of Event: June 4, 2013
Report Date: June 4, 2013
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: K080639
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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.

Description of Event or Problem · 1

ON (B)(6) 2013, THE PATIENT CONTACTED AND ANIMAS REPRESENTATIVE AND ALLEGED THE FOLLOWING: AT THE TIME OF THE CALL, HIS BLOOD GLUCOSE (BG) WAS F 50MG/DL AND FELT LIKE HE WAS GOING TO PASS OUT. HE STATED THAT HE WAS AT THE ER AT THIS TIME AND ON AN IV . PATIENT STATED, HE HAD NO TIME TO TROUBLESHOOT THE PUMP, AND HUNG UP WHEN HE WAS ASKED TO CALL BACK PRIOR TO DISCHARGE TO TROUBLESHOOT THE PUMP. THE ANIMAS REPRESENTATIVE CALLED BACK AND WAS TOLD THE PATIENT WAS UNABLE TO TROUBLESHOOT AT THAT TIME, BUT THAT THE ¿BUT THE PUMP WAS WORKING RIGHT AND THAT CAUSED HIM TO BE IN THE HOSPITAL. ALTHOUGH NO SPECIFIC EVIDENCE OF PUMP MALFUNCTION, DEFECT, OR MISUSE WAS REPORTED, THIS COMPLIANT IS BEING MADE DUE TO THE POSSIBILITY THAT THE USE OF AN INSULIN PUMP MAY HAVE CONTRIBUTED IN AN UNIDENTIFIED MANNER TO THE HYPOGLYCEMIA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
298050	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR		Hospitalization