ACCU-CHEK ® SPIRIT COMBO

MDR report key: 3965113 · Received July 29, 2014

Report

Report Number: 1823260-2014-05651
Event Type: Injury
Date Received: July 29, 2014
Date of Event: July 8, 2014
Report Date: July 29, 2014
Manufacturer: ROCHE DIAGNOSTICS
Product Code: LZG
PMA / PMN Number: NA
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE EVENT OCCURRED IN (B)(6). PATIENT DECLINED TO RETURN PRODUCT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT'S MOTHER ALLEGES THAT THE INFUSION DEVICE MAY HAVE BEEN DELIVERING AN INACCURATE AMOUNT OF INSULIN. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS ELEVATED AND CORRECTION WITH THE INFUSION DEVICE WAS NOT SUCCESSFUL EVEN AFTER CHANGING THE DEVICE'S ACCESSORIES. THE PATIENT VOMITED AND WAS TAKEN TO THE HOSPITAL WHERE HIS BLOOD GLUCOSE LEVEL WAS 380 MG/DL. THE PATIENT WAS TREATED WITH INSULIN VIA A PERFUSOR. THE PATIENT HAS AN INFECTION AND IS TAKING ANTIBIOTICS FOR IT. THE FAMILY IS ON VACATION AND DECLINED TO HAVE THE DEVICE REPLACED OR RETURN THE DEVICE FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
441355	ACCU-CHEK ® SPIRIT COMBO	INSULIN INFUSION PUMP	LZG	ROCHE DIAGNOSTICS	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	006 YR		Hospitalization\| R	UNKNOWN ANTIBIOTIC