ACCU-CHEK ® RAPID-D INFUSION SET

Report

Report Number: 3011393376-2016-04087
Event Type: Injury
Date Received: June 23, 2016
Date of Event: December 30, 2015
Report Date: July 5, 2017
Manufacturer: ROCHE DIABETES CARE, INC.
Product Code: FPA
Removal / Correction Number: NA
Adverse Event: 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).WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE ORSIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

Additional Manufacturer Narrative · 1

CORRECTED PRODUCT IN FIELD.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS DUE TO A BENT CANNULA. THE READINGS OBTAINED WERE 22 MMOL/L AND 25 MMOL/L. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2015 TO (B)(6) 2016. PATIENT RECEIVED AN "INSULIN IV" FOR TREATMENT OF THE ELEVATED BLOOD GLUCOSE LEVELS. IT IS UNKNOWN WHAT KIND OF INSULIN WAS PROVIDED OR HOW MUCH. PRODUCT WILL NOT BE RETURNED FOR EVALUATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS DUE TO A BENT CANNULA. THE READINGS OBTAINED WERE 22 MMOL/L AND 25 MMOL/L. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2015 TO (B)(6) 2016. PATIENT RECEIVED AN "INSULIN IV" FOR TREATMENT OF THE ELEVATED BLOOD GLUCOSE LEVELS. IT IS UNKNOWN WHAT KIND OF INSULIN WAS PROVIDED OR HOW MUCH. PRODUCT WILL NOT BE RETURNED FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
400367	ACCU-CHEK ® RAPID-D INFUSION SET	SUBCUTANEOUS INFUSION SET	FPA	ROCHE DIABETES CARE, INC.		ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	29 YR		Hospitalization\| R	UNKNOWN INSULIN