ACCU-CHEK ® FLEXLINK INFUSION SET

Report

Report Number: 1823260-2014-04707
Event Type: Injury
Date Received: June 26, 2014
Date of Event: June 3, 2014
Report Date: September 18, 2014
Manufacturer: ROCHE DIAGNOSTICS
Product Code: FPA
PMA / PMN Number: NA
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE EVENT OCCURRED IN (B)(6). THE INSULIN PUMP WAS EVALUATED AND NO ISSUES WERE IDENTIFIED WITH THE PUMP HOWEVER A SMALL CUT WAS FOUND IN THE TUBING OF THE TRANSFER SET NEAR THE LUER. THIS WOULD ALLOW INSULIN LEAKAGE. IF THERE IS A LEAK THE INSULIN PUMP WOULD NOT PRODUCE AN OCCLUSION ERROR BECAUSE THERE IS STILL A PATHWAY FOR THE FLOW OF INSULIN. SUSPECT PRODUCT WAS CHANGED FROM THE INSULIN PUMP TO THE TRANSFER SET. THE INVESTIGATION DETERMINED THE CAUSE OF THE LEAK TO BE USER ERROR.

Additional Manufacturer Narrative · 1

THE EVENT OCCURRED IN (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL WAS ELEVATED TO 510 MG/DL. THE PATIENT FELT DIZZY AND SICK AND AFTER A PERIOD OF TIME PASSED WENT TO THE EMERGENCY ROOM. HER BLOOD GLUCOSE LEVEL WAS 450 MG/DL AT THE HOSPITAL AND THE PATIENT WAS GIVEN AN IV CONTAINING INSULIN. THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. THE HOSPITAL STATED THE CAUSE OF THE ELEVATED BLOOD GLUCOSE LEVEL WAS AN OBSTRUCTION OF THE INFUSION SET. THE PATIENT'S INFUSION DEVICE DID NOT DISPLAY E4 (OCCLUSION ERROR). THE INFUSION DEVICE AND INFUSION SETS WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
374378	ACCU-CHEK ® FLEXLINK INFUSION SET	SUBCUTANEOUS INFUSION SET	FPA	ROCHE DIAGNOSTICS	NA	5041965

Patients

Seq	Age	Sex	Outcome	Treatment
1	032 YR		Hospitalization\| R