ACCU-CHEK ® SPIRIT COMBO

MDR report key: 3970470 · Received July 31, 2014

Report

Report Number: 1823260-2014-05740
Event Type: Injury
Date Received: July 31, 2014
Date of Event: July 16, 2014
Report Date: September 19, 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: BR
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE EVENT OCCURRED IN (B)(6).

Description of Event or Problem · 1

REPORTER STATED THE CUSTOMER WAS HOSPITALIZED WITH HYPERGLYCEMIA, AND THE CUSTOMER BELIEVES THE INSULIN DELIVERY OF THE INFUSION DEVICE IS TOO LOW. SHE WAS VOMITING, HAD DIARRHEA, AND FELT TINGLING IN HER CHEST AND BACK. HER BLOOD GLUCOSE WAS 400 MG/DL AT HOME AND "HI" (>600 MG/DL) AT EMERGENCY CARE, AND SHE WAS TREATED WITH AN IV DRIP AND 50.0 UNITS OF INSULIN. HER BLOOD GLUCOSE DECREASED TO 280 MG/DL AFTER SOME TIME AND THEN INCREASED TO 350 MG/DL AT 12:00 P.M. ON (B)(6) 2014. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
448063	ACCU-CHEK ® SPIRIT COMBO	INSULIN INFUSION PUMP	LZG	ROCHE DIAGNOSTICS	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	042 YR		Hospitalization\| R	HYPERTENSION MEDICATION\| DIURETIC\| CHOLESTEROL MEDICATION