FDA Adverse Event Injury Summary report: N

QUICK CHECK BLOOD GLUCOSE MONITORING STRIP

MDR report key: 23263 · Received July 7, 1995

Report

Report Number
MW1006439
Event Type
Injury
Date Received
July 7, 1995
Date of Event
May 26, 1995
Report Date
June 21, 1995
Manufacturer
CAN-AM CARE CORP.
Product Code
CFR
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

PT'S BLOOD SUGARS AT HOME HAVE BEEN RUNNING BETWEEN 94 AND 117 THROUGHOUT THE DAY BUT HE IS HAVING NOCTURIA, POLYURIA, AND POLYDIPSIA WITH INCREASING THIRST AND URINATION AT LEAST EVERY 2 HOURS. HE ALSO COMPLAINS OF DRY MOUTH. A DISCUSSION OF HIS DIETARY HABITS INDICATES THAT IT IS HIGH IN FAT. PT'S WIFE WAS ASKED TO BRING IN HIS HOME GLUCOSE MONITOR. IT WAS FOUND THAT THEY WERE USING GENERIC STRIPS WHICH DID NOT READ HIGH AND WERE NOT APPROPRIATE FOR THE MACHINE AND WERE MISLEADING THE PT WITH REGARD TO HIS BLOOD SUGARS. PT RETURNED TO THE OFFICE WITH HIS UNIT AND WAS RECHECKED BY USING THE STRIPS THAT HE BROUGHT IN WHICH WERE GENERIC BRAND TEST STRIPS WHICH SAID THEY WERE FOR HIS BLOOD GLUCOSE MONITOR. AGAIN, THE PT'S BLOOD SUGAR WAS CHECKED WITH HIS MACHINE AND HIS STRIPS, RESULTS IN THE 100'S. HOWEVER, WHEN NEW STRIPS FROM RPTR'S OFFICE WERE PLACED IN THE MACHINE AND QUALITY CONTROL CHECKS WERE RUN, THE MACHINE WAS READING ACCURATELY BOTH HIGH AND LOW BLOOD SUGARS WITHOUT ERROR. AGAIN HIS BLOOD SUGAR WAS CHECKED ON HIS MACHINE WITH THE STRIPS SUPPLIED BY RPTR'S OFFICE AND RPTR OBTAINED A READING OF 395. THIS IS A COUPLE OF HOURS AFTER INSULIN WAS ADMINISTERED. WHEN THE MACHINE WAS RECHECKED, BLOOD SUGAR ON THE 3RD TIME WAS STILL TOO HIGH TO READ, HOWEVER, THE PT WAS INSTRUCTED TO QUIT USING THE GENERIC STRIPS DUE TO THE INNACURATE RESULTS AND A FRESH SUPPLY OF STRIPS AND CONTROL SOLUTIONS WERE PROVIDED TO THE PT BY THE OFFICE. (*)

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 QUICK CHECK BLOOD GLUCOSE MONITORING STRIP BLOOD GLUCOSE MONITORING STRIP CFR CAN-AM CARE CORP. 41180P

Patients

Seq Age Sex Outcome Treatment
1 71 YR Required Intervention BLOOD GLUCOSE MONITOR