Description of Event or Problem · 1
THE CONTACT REPORTED THAT HIS DAUGHTER, A 13 YEAR OLD TYPE I DIABETIC, OBTAINED INACCURATELY HIGH BLOOD READINGS WITH TEST STRIPS, LOT 16191A. ON APPROX 1/5/97, THE PT OPENED THE FIRST BOTTLE OF TEST STRIPS FROM THE BOX AND OBTAINED GLUCOSE READINGS IN THE 100-200 MG/DL RANGE WHICH SHE DID NOT QUESTION. ON 1/7/97 AT 6:00 PM, THE PT ADMINISTERED 7 UNITS OF REGULAR INSULIN AND 7 UNITS OF NPH WHICH IS HER NORMAL DINNER INSULIN DOSAGE. SHE DID NOT TAKE HER BLOOD GLUCOSE AT THIS TIME. SHE ATE HER DINNER IMMEDIATELY FOLLOWING THE INJECTION (ATE SAUERKRAUT, SAUSAGE, AND BREAD). ON 1/7/97, AT 9:30 PM, THE PT OBTAINED A BLOOD GLUCOSE READING OF 127 MG/DL WITH TEST STRIPS. AT THAT TIME, SHE ATE SAUSAGE AND CHIPS. ON 1/8/97 AT 6:00 AM, THE CONTACT ATTEMPTED TO WAKE THE PT, BUT HE WAS NOT SUCCESSFUL. THE CONTACT STATED THAT THE PT "WAS DROOLING." BECAUSE THEY COULD NOT WAKE THE PT, THE CONTACT'S WIFE IMMEDIATELY CALLED THE PARAMEDICS. WHILE WAITING FOR THE PARAMEDICS TO ARRIVE, THE CONTACT OBTAINED A BLOOD GLUCOSE READING OF 96 OR 97 MG/DL WITH TEST STRIPS. APPROX 5 MINUTES LATER, THE PARAMEDICS ARRIVED AND OBTAINED A BLOOD GLUCOSE READING OF "LO" USING THEIR METER AND TEST STRIPS (TYPE UNK). THE PARAMEDICS GAVE THE PT "MONOJEL" (THEY RUBBED IT IN HER CHEEK) AND THE PT AWOKE APPROX 10 MINUTES LATER. THE PARAMEDICS LEFT AFTER THE PT AWOKE. THE REPRESENTATIVE INQUIRED AS TO WHETHER THE DESICCANT WAS REMOVED FROM THE TEST STRIPS AND THE CONTACT STATED THAT IT WAS REMOVED ON INITIAL OPENING. THE PT'S METER WAS SET TO THE APPROPRIATE CODE WHEN ALL TESTS WERE PERFORMED. IT IS NOT KNOWN WHETHER THE PARAMEDICS' METER WAS SET TO THE APPROPRIATE CODE. IT IS NOT KNOWN WHETHER THE PARAMEDICS' TEST STRIPS WERE TESTED FOR ACCURACY WITH NORMAL CONTROL SOLUTION. WITH THE REPRESENTATIVE, THE CONTACT PERFORMED A NORMAL CONTROL SOLUTION TEST USING TEST STRIPS AND OBTAINED TWO BACK TO BACK TEST RESULTS OF 166 AND 160 MG/DL VERSUS A NORMAL CONTROL SOLUTION RANGE OF 111-167 MG/DL (SOL LOT VG166, EXPIRATION DATE 7/98). THE CONTROL SOLUTION WAS OPENED WITH THE REPRESENTATIVE. THE CONTACT SHOOK IT BEFORE HE APPLIED THE SAMPLE TO THE TEST PAD. ALSO WITH THE REPRESENTATIVE, THE CONTACT OBTAINED TWO CHECK STRIP TEST RESULTS OF 84 AND 80 VERSUS A CHECK STRIP RANGE OF 66-89. THE PT STORES THE TEST STRIPS IN HER BEDROOM. THE REPRESENTATIVE INFORMED THE CONTACT THAT TEST STRIPS ARE FOR USE WITH A SECOND AND THIRD BRAND METERS ONLY.