FDA Adverse Event Malfunction Summary report: N

CELL-DYN 3700 SL ANALYZER

MDR report key: 1894503 · Received November 9, 2010

Report

Report Number: 2919069-2010-00528
Event Type: Malfunction
Date Received: November 9, 2010
Report Date: October 26, 2010
Manufacturer: ABBOTT DIAGNOSTICS DIVISION
Product Code: GKZ
PMA / PMN Number: K980614
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: MEDICAL TECHNOLOGIST

Narratives

Additional Manufacturer Narrative · 1

(B)(4). MEDICAL PRODUCTS, HEMOGLOBIN LYSE LIST (B)(4). HEMCAL PLUS CALIBRATORS LIST 8H57-01, CELL-DYN 26 QC LIST 8H59-01 LOTS UNKNOWN. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

Additional Manufacturer Narrative · 1

(B)(4). A FIELD SERVICE REPRESENTATIVE (FSR) CLEANED VALVES 11, 12, 13, 15, 46, 47, AND 81 IN THE FLOW PANEL; THE FSR REPLACED ALL TUBINGS FOR THESE VALVES AS WELL. THE FSR CHECKED THE SYSTEM VOLTAGE, VACUUM SYSTEM AND PRESSURE; ALL WERE IN GOOD CONDITION. THE INSTRUMENT WAS WITHIN SPECIFICATIONS, NO FURTHER INVESTIGATION WAS REQUIRED. PRODUCT LABELING PROVIDES INSTRUCTIONS FOR PROBLEM IDENTIFICATION, PROBLEM ISOLATION, AND CORRECTIVE ACTION. A NON-STATISTICAL TREND (NST) REVIEW WAS PERFORMED AND NO NST WAS IDENTIFIED DURING THE SEARCHED PERIOD. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE (B)(4) RELATED TO THE REPORTED ISSUE.

Description of Event or Problem · 1

THE ACCOUNT STATED THAT THE CELL-DYN 3700 ANALYZER IS INTERMITTENTLY GENERATING DISCREPANT HEMOGLOBIN RESULTS. THE INITIAL RESULT FOR ONE PATIENT WAS 7.9 G/DL AND THE RETEST RESULT WAS 13.7 G/DL. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CELL-DYN 3700 SL ANALYZER	AUTOMATED HEMATOLOGY ANALYZER	GKZ	ABBOTT DIAGNOSTICS DIVISION		21508AK

Patients

Seq	Age	Sex	Outcome	Treatment
1				ASSAY SOLENOID LIST (B)(4) LOT UNK