ACCU-CHEK SPIRIT

MDR report key: 1890135 · Received October 29, 2010

Report

Report Number: 2183996-2010-02180
Event Type: Injury
Date Received: October 29, 2010
Date of Event: September 20, 2010
Report Date: October 11, 2010
Manufacturer: ROCHE INSULIN DELIVERY SYSTEMS INC.
Product Code: LZG
PMA / PMN Number: K060876
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

NO PRODUCT WILL BE RETURNED FOR EVALUATION.

Description of Event or Problem · 1

ON (B)(6) 2010, BOYFRIEND REPORTED 4 EPISODES OF HYPOGLYCEMIA OVER THE PREVIOUS FEW WEEKS. THE MOST RECENT INCIDENTS WERE ON (B)(6) 2010 AND (B)(6) 2010. BLOOD GLUCOSE WENT AS LOW AS 23 MG/DL AND 44 MG/DL. ONE INCIDENT RESULTED IN PATIENT LOSING CONSCIOUSNESS AND FALLING ON THE FLOOR. PARAMEDICS TRANSPORTED PATIENT TO EMERGENCY ROOM AND ADMINISTERED DEXTROSE. ON DAY OF REPORT, PATIENT "WAS EATING TO BRING BLOOD SUGAR UP." PATIENT'S WEIGHT HAS DECREASED (B)(6). DOCTOR BELIEVES BASAL RATES NEED TO BE ADJUSTED AND ADVISED TO CALL TECHNICAL SUPPORT TO SEE WHAT BASAL RATES SHOULD BE ADJUSTED TO. BOYFRIEND WAS ADVISED TECHNICAL SUPPORT CANNOT PROVIDE MEDICAL ADVICE AND TO SPEAK WITH ENDOCRINOLOGIST OR DIABETES EDUCATOR. DOCTOR BLAMED HYPOGLYCEMIA ON RECENT WEIGHT LOSS. FOLLOW-UP WAS COMPLETED WITH BOYFRIEND. BASAL RATES WERE ADJUSTED DURING THE DAYTIME HOURS. THIS ADJUSTMENT HAS BROUGHT FASTING BLOOD GLUCOSE TO 120-130 MG/DL, WHICH IS AN ACCEPTABLE RANGE, NO PRODUCT WAS REQUESTED FOR EVALUATION.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	41 YR		Hospitalization\| R	INSULIN INFUSION SET\| INSULIN