INFORM
Received May 27, 2005 · Event occurred May 18, 2005
Report 609402 · MDR key 609402
Device
Product problems
- Incorrect Or Inadequate Test Results
- High Test Results
Patient
58 YR
- Edema
- Respiratory arrest
- Blood glucose, low
- Therapy/non-surgical treatment, additional
- Intubation
- Treatment with medication(s)
- Hospitalization required
Narrative
Description of Event or Problem
A PATIENT WITH HISTORY OF DIABETES, CARDIAC EJECTION FRACTION OF 5%, SEVERE PERIPHERAL EDEMA. THE BLOOD SUGAR WAS DRAWN AND SENT TO LAB. THE ACCUCHECK WAS DONE AND THE RESULT WAS 486 IT WAS REPEATED AND THE RESULT WAS 338. SLIDING SCALE INSULIN WAS GIVEN (9UNITS). THE LAB RESULTS WERE CALLED TO FLOOR AND THE RESULTS WERE 30. THE PATIENT WENT INTO RESPIRATORY ARREST & WAS INTUBATED. 3 HOURS LATER THE ACCUCHECK WAS 70, A VENOUS BLOOD SUGAR WAS 12. THE SAME METER DISPLAYED RESULTS OF 104 & 157 FROM FINGERSTICK, 137 FROM EARLOBE, AND A LAB RESULT OF 116 & 117. LAB QA PERSON CHECKED THE EQUIPMENT TO VERIFY CORRECT FUNCTION OF THE DEVICE. THE LAB REPORTS A SIMILAR OCCURRENCE WHERE A PATIENT WHO WAS ON 21 DIFFERENT MEDICATIONS HAD FINGERSTICK RESULTS THAT DID NOT CORRELATE WITH THE LAB RESULTS, EXAMPLE: THE FINGERSTICK WAS 570, AND THE LAB DRAW WAS 169 40 MINUTES LATER. THIS WAS REPORTED TO ROCHE.