inforMED
InjuryCGA

PRODIGY

Received Oct 24, 2013 · Event occurred Sep 22, 2013

Report 3008789114-2013-00039 · MDR key 3449893

Device

Generic name

Prodigy Autocode

Model number

51850

Catalog number

51850

Product problems

  • Incorrect Or Inadequate Test Results

Patient

75 YR

  • Hyperglycemia
  • Sweating

Narrative

Description of Event or Problem

PDC RECEIVED A CALL ON (B)(6) 2013 TO REPORT MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2013 AT 11:30PM. CALLER STATED THAT HIS FATHER-IN-LAW, JS (PT), USED A PRODIGY METER AT 8:30PM AND GOT A READING OF 101MG/DL, SO INSULIN WAS NOT TAKEN. HE SAID THE PT WENT TO BED AT 9PM AND WOKE UP AT 11:30PM SWEATING AND UNABLE TO BREATHE. BASED ON SYMPTOMS, THE PATIENT'S FATHER DROVE HIM TO THE EMERGENCY ROOM IMMEDIATELY, AND DID NOT PERFORM ANOTHER TEST TO CHECK PT'S BLOOD SUGAR WHILE IN THE EMERGENCY ROOM, THEY USED THE PRODIGY METER WHICH GAVE A READING OF 42 G/DL, WHEREAS THE HOSPITAL'S METER READ 44MG/DL. PT WAS GIVEN FOOD AND ORANGE JUICE TO RAISE HIS SUGAR LEVELS, AND WAS ADMINISTERED FLUIDS FROM AN EXISTING PORT. PT SPENT A FEW DAYS IN THE HOSPITAL DUE TO DIFFICULTY BREATHING. CALLER ALSO SAID THAT THE PRODIGY METER READING ON (B)(6) 2013 GAVE A RESULT OF 42MG/DL, WHILE THE HOSPITAL'S METER READ OVER 300 MG/DL. PER CALLER, LAST METER READINGS ARE: 7-DAY AVG 210MG/DL, 14-DAY AVG 139 MG/DL, 28-DAY AVG 170MG/DL, 10/02 8:55PM 182 MG/DL, (B)(6) 7AM 137 MG/DL, (B)(6) 8:20PM 82MG/DL, (B)(6) 12:25PM 301MG/DL, (B)(6) 10:16 AM 352MG/DL. PRODIGY SENT A REPLACEMENT METER AND CS, WITH A PREPAID ENVELOPE SO PT CAN RETURN SUSPECT PRODUCT(S) FOR EVAL.