FDA Adverse Event Injury Summary report: N

COZMO INSULIN PUMP

MDR report key: 2982178 · Received September 27, 2006

Report

Report Number: 2183502-2006-00129
Event Type: Injury
Date Received: September 27, 2006
Date of Event: August 23, 2006
Report Date: September 26, 2006
Manufacturer: SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
Product Code: LZG
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: LAY USER/PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

Description of Event or Problem · 1

INFO WAS REC'D THAT REPORTED A PT WAS HOSPITALIZED ON (B)(6) 2006 DUE TO HYPERGLYCEMIA. THE RPTR STATES THAT THEY PERFORMED A SITE AND SET CHANGE ON (B)(6) 2006. SHE REPORTS THAT HER BLOOD GLUCOSE LEVELS WERE "HIGH" ON (B)(6) 2006. ON (B)(6) 2006 AT 0300 SHE AWOKE AND HER BLOOD GLUCOSE WAS "HIGH" ON 2 DIFFERENT METERS, SHE TOOK A BOLUS AND WENT BACK TO BED. AT 0430 SHE WAS FEELING ILL AND HER BG'S WERE STILL HIGH, SHE TOOK ANOTHER BOLUS BY 0500 SHE WAS VOMITING. SHE WENT TO HER YOGA, MEDITATION, AIKIDO CLASSES THAT DAY. BY 1700 HER BLOOD GLUCOSE WAS DOWN TO 430 AND SHE WAS FEELING BETTER. AT 1900 SHE WAS BACK UP TO 470 AND SHE WENT TO THE HOSPITAL. AT 1900 SHE WAS BACK UP TO 470 AND SHE WENT TO THE HOSPITAL. UPON ADMIT HER BLOOD GLUCOSE WAS 462. THE DEVICE WILL BE RETURNED FOR EVAL; TO ENSURE THAT IT IS FUNCTIONING CORRECTLY AND DID NOT CONTRIBUTE TO THE REPORTED INCIDENCE, BUT AS OF THE DATE OF THIS REPORT HAD NOT BEEN RETURNED FOR EVAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COZMO INSULIN PUMP	INSULIN PUMP	LZG	SMITHS MEDICAL MD (FORMERLY DELTEC, INC)	1700	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	23 YR		Hospitalization