Description of Event or Problem · 1
MEDICAL AFFAIRS HAS BEEN UNABLE TO GET A HOLD OF THE PATIENT'S FAMILY MEMBER AND WILL BE SENDING A LETTER TO OBTAIN MORE CLINICAL INFORMATION. PATIENT WOKE UP AT 4:45A.M SCREAMING. FAMILY MEMBER TOOK PATIENT'S BLOOD GLUCOSE AT 4:46A.M AND OBTAINED A 44MG/DL. FAMILY MEMBER GAVE PATIENT A SODA AND AT 4:53 AM FAMILY MEMBER RETESTED PATIENT AND OBTAINED A 200 MG/DL. FAMILY TOOK PATIENT TO THE HOSPITAL WHERE THEY DID A BLOOD TEST ON THE HOSPITAL METER AND OBTAINED A READING OF 297 MG/DL. LAB TEST WAS DONE; HOWEVER, FAMILY MEMBER DID NOT RECEIVE THE RESULTS AT THE TIME OF THE CALL. PATIENT WAS TREATED WITH INSULIN AND WAS GIVEN BREAKFAST, WHICH INCLUDED, CEREAL, YOGURT, BACON,EGGS AND BISCUITS. AT 6:15AM, WHILE IN THE HOSPITAL A BLOOD GLUCOSE TEST WAS DONE, AND THE PATIENT'S READING WAS 37 MG/DL. NO INFORMATION ON WHETHER THAT WAS ON PATIENT'S METER OR ON THE HOSPITAL METER. PATIENT MAY OR MAY NOT BE ADMITTED IN THE HOSPITAL. CONTROL SOLUTION TEST WAS DONE AND IT PASSED 122(101-137). TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS DONE CORRECTLY. TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. BASED ON THE INFORMATION PROVIDED, THIS CASE IS BEING REPORTED AS A MALFUNCTION, SINCE THE RESULTS OF 44MG/DL AND 200MG/DL WITH A LIFESCAN METER WAS PERFORMED WITHIN 7 MINUTES OF EACH OTHER EXCEDS THE EXPECTED VALUE OF <=20% AND/OR<=20MG/DL, THEREBY INDICATING A POTENTIAL MALFUNCTION OF THE METER IN TERMS OF PRECISION.