FDA Adverse Event Injury Summary report: N

PUMP MMT-722CAL PRDGM INS V2.2 CL EN PR

MDR report key: 1030037 · Received April 14, 2008

Report

Report Number: 2032227-2008-00634
Event Type: Injury
Date Received: April 14, 2008
Date of Event: April 4, 2008
Report Date: April 4, 2008
Manufacturer: MEDTRONIC MINIMED
Product Code: LZG
PMA / PMN Number: P980022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW, ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

Description of Event or Problem · 1

THE CUSTOMER'S FATHER WANTED TO HAVE THE INSULIN PUMP REPLACED, BECAUSE THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. THE FATHER STATED THAT THE CUSTOMER WAS HAVING HIGH BLOOD GLUCOSE LEVELS IN THE EVENING AND THE CUSTOMER CHANGED THE INFUSION SET. THE FATHER STATED THAT HE PERFORMED THE PRIME TEST AT THE HOSPITAL AND HE NEVER SAW ANY INSULIN COME OUT OF THE TUBING. THE INSULIN PUMP WAS PROGRAMMED CORRECTLY, BUT THE FATHER DID NOT HAVE THE TUBING CLAMP TO PERFORM THE HIGH PRESSURE TEST. THE FATHER ALSO MENTIONED THAT THE INSULIN PUMP HAD A CRACK IN THE RESERVOIR COMPARTMENT. THE INSULIN PUMP GAVE AN ALARM ON THE NIGHT OF THE HOSPITALIZATION AS WELL. NOTHING FURTHER WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PUMP MMT-722CAL PRDGM INS V2.2 CL EN PR	INFUSION PUMP	LZG	MEDTRONIC MINIMED	MMT-722CAL

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization