FDA Adverse Event Malfunction Summary report: N

ACCU-CHEK FLEXLINK PLUS

MDR report key: 2063333 · Received April 11, 2011

Report

Report Number
2183996-2011-00938
Event Type
Malfunction
Date Received
April 11, 2011
Date of Event
March 12, 2011
Report Date
March 12, 2011
Manufacturer
ROCHE INSULIN DELIVERY SYSTEMS, INC.
Product Code
FRN
PMA / PMN Number
K100704
Removal / Correction Number
Z-1487-2011
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
KS, US
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

ON (B)(6) 2011, PATIENT REPORTED ELEVATED BLOOD GLUCOSE DUE TO THE INFUSION CANNULAS "CURLING AROUND." PATIENT USED THE INFUSION SET FOR THE FIRST TIME ON THE NIGHT OF THE REPORT. TWO INFUSION CANNULAS THAT HE INSERTED BENT IN A CIRCLE, AND BLOOD GLUCOSE ELEVATED ABOVE 200 MG/DL. HE INSERTED A THIRD INFUSION CANNULA WHICH APPEARED TO BE WORKING AS INTENDED, BUT HE DID HAVE DIFFICULTY WITH INSERTION. NORMAL BLOOD GLUCOSE IS 70-120 MG/DL. INSERTION DEVICE WAS USED TO INSERT THE INFUSION SET. BLOOD GLUCOSE ELEVATED TO 220 MG/DL FOLLOWING INSERTION OF THE FIRST INFUSION SET, AND PATIENT DELIVERED A 14 UNIT BOLUS. ONE HOUR LATER, HIS BLOOD GLUCOSE WAS 235 MG/DL. HE DELIVERED AN ADDITIONAL 14 UNITS OF INSULIN. HE WAITED 20 MINUTES AND REMOVED THE INFUSION SET AFTER HIS BLOOD GLUCOSE DID NOT DECREASE. THE CANNULA WAS BENT IN A COMPLETE CIRCLE. HE INSERTED A NEW INFUSION SET, BOLUSED 14 UNITS, AND WENT TO BED. ONE HOUR LATER, HIS BLOOD GLUCOSE WAS STILL OVER 200 MG/DL. HE REMOVED THE INFUSION SET, AND THE CANNULA WAS AGAIN BENT IN A CIRCLE. THE THIRD INFUSION SET DID NOT INSERT CORRECTLY WITH THE INSERTION DEVICE, AND HE HAD TO MANUALLY PRESS IT IN. THERE WAS NO INSULIN LEAKAGE. INFUSION SETS WERE REPLACED AND REQUESTED FOR EVALUATION. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ACCU-CHEK FLEXLINK PLUS INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS, INC. NA GWX122

Patients

Seq Age Sex Outcome Treatment
1 72 YR INSULIN| INSULIN INFUSION DEVICE