FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON
MDR report key: 71917
·
Received February 21, 1997
Report
- Report Number
- 2050012-1997-00003
- Event Type
- Malfunction
- Date Received
- February 21, 1997
- Date of Event
- January 27, 1997
- Report Date
- January 29, 1997
- Manufacturer
- BECKMAN INSTRUMENTS, INC.
- Product Code
- JJC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Description of Event or Problem · 1
CUSTOMER INITIALLY RAN A PT SAMPLE FOR PHENYTOIN AND MISINTERPRETED THE SYSTEM FLAG "RESULTS SUPPRESSED-AIR" FOR THE PT PHENYTOIN RESULT. CUSTOMER THEN DILUTED THE PT SPECIMEN WITH DI WATER, WHICH CONFLICTS WITH THE WRITTEN DILUTION PROTOCOL IN THE LABELING. CUSTOMER RAN THE DILUTED SPECIMEN AND AGAIN THE SYSTEM APPROPRIATELY FLAGGED THE RESULTS AS "RESULTS SUPPRESSED-AIR" CUSTOMER THEN REPORTED A PT PHENYTOIN RESULT OF <2.5 UG/ML. ACTUAL PHENYTOIN LEVEL WAS APPROXIMATELY 52 UG/ML. ADD'L PHENYTOIN WAS ADMINISTERED BASED ON <2.5 RESULT AND PT BECAME COMATOSE. PHENYTOIN WAS DISCONTINUED AND PT RECOVERED AND WAS RELEASED FROM ICU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON | CLINICAL CHEMISTRY ANALYZER S/W VER. 4.6 | JJC | BECKMAN INSTRUMENTS, INC. | CX7 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |