C8000 CALCIUM
Received Mar 27, 2007 · Event occurred Feb 26, 2007
Report 2018433-2007-00005 · MDR key 924218
Device
Generic name
Calcium
Manufacturer
Abbott Manufacturing, Inc.Model number
NACatalog number
7D61-20
Lot number
44064HW00
Product problems
- Incorrect Or Inadequate Test Results
Patient
NO INFO
- No Consequences Or Impact To Patient
- Therapy/non-surgical treatment, additional
- Hospitalization required
Narrative
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. A FINAL REPORT WILL BE SUBMITTED AT THE CONCLUSION OF AN INVESTIGATION.
Description of Event or Problem
THE CUSTOMER STATES THAT A FEMALE PT COMPLAINING OF THIRST WITH SIGNS OF DEHYDRATION AND ON CALCIUM SUPPLEMENTS GENERATED AN INITIAL ARCHITECT C8000 CALCIUM ASSAY RESULT OF 4.4 MMOL/L (17.6 MG/DL). THE SAMPLE WAS RETESTED AND GENERATED A RESULT OF 4.14 MMOL/L (16.56 MG/DL). THE PT WAS HOSPITALIZED AND BLOOD WAS REDRAWN THAT GENERATED A CALCIUM RESULT OF 2.4 MMOL/L (9.6 MG/DL). THE INITIAL SAMPLE WAS THEN RETESTED AND GENERATED A RESULT OF 2.14 MMOL/L (8.56 MG/DL). THE CUSTOMER STATES THAT, THE INITIAL SAMPLE ARRIVED AT THEIR LAB LATE ON A FRIDAY, WAS CENTRIFUGED AND STORED AT 4 DEGREES CENTIGRADE ON GEL OVER THE WEEK-END. THE SAMPLE WAS TESTED THE FOLLOWING MONDAY MORNING. CONTROLS WERE WITHIN SPECS. THE PT WAS RELEASED FROM THE HOSPITAL WITH NO FURTHER IMPACT TO PT MGMT REPORTED.