ACCU-CHEK SPIRIT

MDR report key: 1082006 · Received July 23, 2008

Report

Report Number: 2183996-2008-01072
Event Type: Malfunction
Date Received: July 23, 2008
Date of Event: July 11, 2008
Report Date: July 11, 2008
Manufacturer: DISETRONIC MEDICAL SYSTEMS, INC.
Product Code: LZG
PMA / PMN Number: K060876
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

NO PRODUCT WILL BE RETURNED FOR EVALUATION.

Description of Event or Problem · 1

IN 2008, THE PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF OVER 230 MG/DL THIS MORNING AND HE FELT THIRSTY. HE STATED THAT HE CHANGED ALL OF HIS ACCESSORIES, AND BOLUSED 11.5 UNITS OF INSULIN AND HIS BLOOD GLUCOSE CONTINUES TO INCREASE. HE WAS ADVISED TO SWITCH TO HIS BACKUP INFUSION DEVICE AND HE DECLINED. THE PATIENT CALLED BACK LATER IN THE SAME DAY, AND STATED THAT HIS BLOOD GLUCOSE MEASURED OVER 170 MG/DL AND HE HAD NOT EATEN ALL DAY. HE STATED THAT HE CHANGED THE INSULIN CARTRIDGE AND IN,FUSION SET. HE HAS BEEN IN CONTACT WITH HIS TRAINER ON A DAILY BASIS, AND HE ALSO LEFT A MESSAGE WITH HIS PHYSICIAN. HE STATED THAT HE WILL BE AWAY FOR 5 WEEKS. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCU-CHEK SPIRIT	INSULIN INFUSION PUMP	LZG	DISETRONIC MEDICAL SYSTEMS, INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	INSULIN INFUSION SET\| INSULIN