FDA Adverse Event Injury Summary report: N

SURESTEP

MDR report key: 288433 · Received July 28, 2000

Report

Report Number
2939301-2000-00582
Event Type
Injury
Date Received
July 28, 2000
Date of Event
June 22, 2000
Report Date
June 30, 2000
Manufacturer
LIFESCAN, INC.
Product Code
CGA
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
PA, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

ON 6/29/2000, THE PARENT OF A DIABETIC STILL IN THE "HONEYMOON" PHASE REPORTED THAT PT'S METER READ "100'S OF POINTS" LOWER THAN PT'S PHYSICIAN'S METER. ON 6/21/2000, THE CHILD WAS ILL AND VOMITING AND REMAINED HOME FROM SCHOOL. THE ILLNESS PERSISTED ON 6/22/200 LEADING TO A HOSP EMERGENCY ROOM VISIT. MULTIPLE RESULTS OBTAINED ON THE PT'S METER ON 6/21 AND 6/22/2000 WERE IN THE 16 TO 18 MMOL/L RANGE. A LAB TEST (VENOUS) AT THE HOSP WAS 386 MG/DL, (WITH A POSITIVE KETONES TEST) SO THE PT WAS GIVEN IV INSULIN. ON 6/25/2000, COMPARISONS WERE DONE WITH A HOSP SURESTEP METER, THE PT'S METER, AND A SECOND PT SURESTEP METER KEPT AT SCHOOL WITH RESULTS OF 193 MG/DL, 10.8 MMOL/L, AND 183 MG/DL, RESPECTIVELY. THE REPORTER MENTIONED THE PT'S HOME METER MAY HAVE BEEN INADVERTENTLY SET IN MMOL/L AS EARLY AS 4/2000 WHEN A NURSE HELPED PT ADJUST THE TIME SETTING. CO CONCLUDES THIS EVENT PROBABLY RESULTED BECAUSE THE USER WAS EVALUATING MEASUREMENTS EXPRESSED IN MMOL/L AS IF THEY WERE EXPRESSED IN MG/DL. (THE REPORTED CONCENTRATIONS ARE SUBSTANTIALLY THE SAME WHEN TRANSLATED FROM MG/DL TO MMOL/L SUGGESTING THE METER WAS WORKING PROPERLY.)

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SURESTEP BLOOD GLUCOSE MONITORING KIT/SYSTEM CGA LIFESCAN, INC. NA NA

Patients

Seq Age Sex Outcome Treatment
1 8 YR Life Threatening| R