FDA Adverse Event Other Summary report: N

CD3200SL 110

MDR report key: 958788 · Received April 26, 2007

Report

Report Number: 2919069-2007-00057
Event Type: Other
Date Received: April 26, 2007
Report Date: February 6, 2007
Manufacturer: ABBOTT DIAGNOSTICS DIVISION/CELLDYN
Product Code: GKZ
PMA / PMN Number: K972354
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER CHECKED THE CELL-DYN 3200 HEMOGLOBIN (HGB) OUTPUT (4.80) AND HGB REFERENCE VALUE (1960, RANGE = 1250 +/-250). THE CUSTOMER ALSO CHECKED FOR SYRINGE MOVEMENT AND LEAKAGE AND NOTICED A BLACK STICKY SUBSTANCE ON THE PLUNGER OF THE SYRINGE. THE TYPE OF SYRINGE WAS NOT SPECIFIED (POSSIBLY SAMPLE SYRINGE OR HGB SYRINGE). THE SYRINGE WAS CLEANED AND A NEW SYRINGE WAS ORDERED. THE CUSTOMER WAS ALSO INSTRUCTED TO CLEAN THE HGB FLOW CELL. THE CUSTOMER STATED THAT DATA WAS ACCEPTABLE AFTER CLEANING THE SYRINGE AND THE HGB FLOW CELL.THE CELL-DYN 3200 SYSTEM OPERATOR'S MANUAL PROVIDES INSTRUCTIONS REGARDING NON SCHEDULED MAINTENANCE FREQUENCY INCLUDING CLEANING THE HGB FLOW CELL AND REPLACING SYRINGES. A REVIEW OF COMPLAINT TRENDING REPORTS DID NOT INDICATE ANY ADVERSE TREND FOR CELL-DYN 3200, LIST 4H60-01, FOR THE COMPLAINT ISSUE. THIS THE FINAL REPORT.

Description of Event or Problem · 1

THE CUSTOMER STATED THAT A LOW HEMOGLOBIN RESULT OF 5 G/DL WAS GENERATED ON THE CELL-DYN 3200 ANALYZER. THE SAME PT WAS REDRAWN AND TESTED ON THE CELL-DYN 3200 ANALYZER GENERATING A HEMOGLOBIN RESULT OF 12 G/DL. THE CUSTOMER QUESTIONED THE LOW RESULT AND DID NOT REPORT THE RESULT OUT OF THE LAB. THERE WAS NO IMPACT TO PT MANAGEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CD3200SL 110	AUTOMATED HEMATOLOGY ANALYZER	GKZ	ABBOTT DIAGNOSTICS DIVISION/CELLDYN	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN