FDA Adverse Event Summary report: N

QUICK CHECK ONE

MDR report key: 52732 · Received November 22, 1996

Report

Report Number
2027242-1996-09063
Date Received
November 22, 1996
Date of Event
September 20, 1996
Report Date
November 22, 1996
Manufacturer
DIAGNOSTIC SOLUTIONS, INC.
Product Code
CFR
Report Source
Manufacturer report
Reporter Location
VA, US
Reporter Occupation
INVALID DATA

Narratives

Description of Event or Problem · 1

THE CONTACT REPORTED THAT HER HUSBAND, A TYPE II DIABETIC ON INSULIN, OBTAINED INACCURATELY LOW BLOOD GLUCOSE READINGS WITH TEST STRIPS. UPON INITIAL OPENING, THE PT OBTAINED RESULTS IN THE 143-163 MG/DL RANGE WHICH HE DID NOT QUESTION. ON 9/15/96, THE PT BEGAN TO OBTAIN BLOOD GLUCOSE READINGS IN THE 90 MG/DL RANGE. BECAUSE HE NOTICED THE DECREASE IN HIS READINGS, HE DISCONTINUED USE OF HIS INSULIN ON 9/20/96. SOME TIME LAST WEEK, THE PT WENT TO HIS PHYSICIAN'S OFFICE BECAUSE HE BEGAN TO QUESTION THE LOWER BLOOD GLUCOSE READINGS HE WAS OBTAINING. BY THIS TIME, THE PT'S TYPICAL BLOOD GLUCOSE READINGS HAD DECREASED TO THE 50MG/DL RANGE. AT HIS PHYSICIAN'S OFFICE, THE PT HAD A VENOUS BLOOD GLUCOSE SAMPLE (SERUM) DRAWN. IMMEDIATELY FOLLOWING THE LAB TEST, THE PT OBTAINED A BLOOD GLUCOSE RESULT OF 90 MG/DL WITH TEST STRIPS. APPROX 2 TO 3 DAYS AFTER THE LAB TEST WAS TAKEN, THE PT'S PHYSICIAN INFORMED HIM THAT HIS VENOUS BLOOD GLUCOSE (SERUM) WAS IN THE 300 MG/DL RANGE (CONTACT COULD NOT REMEMBER SPECIFIC RESULT). AT THIS TIME, THE PT'S PHYSICIAN ADVISED THAT HE RESUME HIS REGULAR INSULIN DOSAGE (CONTACT DOES NOT KNOW PT'S TYPICAL INSULIN REGIMEN) AND DISCONTINUE USE OF THE TEST STRIPS. THE CONTACT COULD NOT PERFORM A CHECK STRIP TEST WITH THE REPRESENTATIVE BECAUSE HER HUSBAND HAD THE METER AND WAS NOT AT HOME. HOWEVER, SHE STATED THAT A CHECK STRIP TEST WAS PERFORMED SOME TIME IN AUGUST OF 196 AND THE RESULT WAS WTHIN THE CHECK STRIP RANGE. ON 10/20/96, THE PT PERFORMED A NORMAL CONTROL SOLUTION TEST AND OBTAINED AN OUT OF RANGE RESULT (THE CONTACT DOES NOT KNOW THE SPECIFIC RESULT). THE CONTROL SOLUTION WAS PURCHASED LAST WEEK AND IS WITHIN THE SHELF LIFE DATE. THE DESICCANT WAS REMOVED FROM THE BOTTLE OF TEST STRIPS ON 10/20/96. THE PT'S METER WAS SET TO THE APPROPRIATE CODE WHEN ALL TESTS WERE PERFORMED. THE PT STORES HIS TEST STRIPS IN HIS BEDROOM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 QUICK CHECK ONE BLOOD GLUCOSE TEST STRIPS FOR USE WITH ONE TOUCH NETERS CFR DIAGNOSTIC SOLUTIONS, INC. * 16079A

Patients

Seq Age Sex Outcome Treatment
1 *