• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC.FREESTYLE LITE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT DIABETES CARE INC. FREESTYLE LITE   Back to Search Results
Lot Number 1366118
Event Date 11/14/2013
Event Type  Death   Patient Outcome  Death
Event Description

A pt using freestyle lite test strips (lot #1366118) in an omnipod meter/control unit had repeated erroneously low glucose readings. Because she had faulty info she did not recognize the onset of hyperglycemia and then diabetic ketoacidosis. She subsequently died. The suspect test strips and meter were in my possession on (b)(6) 2013. I tested the suspect strips/meter with normal freestyle control solution and received a reading of 23 mg/dl. I immediately repeated the test on the same meter with freestyle lite strips of a different lot (#1361309) with a correct reading of 90 mg/dl. I and an employee both did "in vivo" testing using first our personal meters and then the suspect equipment. My employee had a glucose of 180 (on two other devices) with a reading of 36 on the suspect equipment. I had a reading of 109 on my meter and 26 on the suspect equipment. This clearly indicated that the strips/meter in the pt's possession at the time of death were reporting erroneously low glucose levels.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFREESTYLE LITE
Type of DeviceFREESTYLE LITE
Manufacturer (Section F)
ABBOTT DIABETES CARE INC.
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
Device Event Key3558975
MDR Report Key3530664
Event Key3427239
Report NumberMW5033513
Device Sequence Number1
Product CodeNBW
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 12/16/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device LOT Number1366118
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? Yes
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 12/17/2013 Patient Sequence Number: 1
#TreatmentTreatment Date
OMNIPOD METER
FREESTYLE LITE STRIPS
TANDEM GLUCOSE PUMP
NOVOLOG INSULIN
-
-