FDA Adverse Event Injury Summary report: N

ACCU-CHEK SPIRIT

MDR report key: 1855167 · Received September 30, 2010

Report

Report Number: 2183996-2010-02005
Event Type: Injury
Date Received: September 30, 2010
Date of Event: September 19, 2010
Report Date: September 20, 2010
Manufacturer: ROCHE INSULIN DELIVERY SYSTEMS INC.
Product Code: LZG
PMA / PMN Number: K060876
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: UNKNOWN

Narratives

Description of Event or Problem · 1

ON (B)(6) 2010, PT REPORTED HE IS HAVING VERY ERRATIC RESULTS THAT ARE UNEXPLAINABLE OTHER THAN HE THINKS THE INFUSION DEVICE IS AT FAULT. PT STATED HIS BLOOD GLUCOSE THIS WEEK HAS BEEN AS ELEVATED AS 500 MG/DL AND AS LOW AS 40 MG/DL WHICH OCCURRED ON (B)(6) 2010. PT REPORTED HE EXPERIENCED SEVERE LOW BLOOD GLUCOSE SYMPTOMS BUT WAS ABLE TO SELF TREAT. PT'S NORMAL BLOOD GLUCOSE RANGE IS AROUND 100 MG/DL. PT STATED HE HAS HAD NO CHANGES IN HIS ROUTINE OTHER THAN INCONSISTENT INSULIN DELIVERY. PT REPORTED THIS HAS BEEN AN ONGOING ISSUE. PT STATED THE INSULIN DEVICE HAS NOT GIVEN ANY ERROR MESSAGES. VERIFIED THE BOLUS HISTORY OF THE INFUSION DEVICE MATCHES WHAT HE HAS PROGRAMMED. PT REPORTED HE DOES WEAR THE INFUSION DEVICE WHILE EXERCISING AND IT GETS SWEATY BUT HE WIPES IT OFF. PT STATED HE DOES DRINK ALCOHOL AT TIMES. PT REPORTED HE HAS NOT MET WITH HIS TRAINER. SUBMITTED REQUEST FOR ADDITIONAL TRAINING. PT STATED HE IS GOING TO START SEEING AN ENDOCRINOLOGIST SOON. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

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	57 YR		Required Intervention	INSULIN\| INSULIN INFUSION SET