IMMAGE IMMUNOCHEMISTRY SYSTEM IMMAGE SYSTEM 120V 470000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-20 for IMMAGE IMMUNOCHEMISTRY SYSTEM IMMAGE SYSTEM 120V 470000 manufactured by Beckman Coulter, Inc..

Event Text Entries

[2388741] On (b)(4) 2012, customer reported that the immage system generated false positive rheumatoid factor (rf) results for 17 patient samples. Customer stated that no erroneous results were reported out of the laboratory. Customer was using rf reagent lot m103174. Customer stated that they run rf in duplicate, and when the duplicates do not match they repeat the samples. Customer stated that the instrument performed within expected ranges for accuracy and precision, that quality control (qc) was good, and qc run before and after the event was also good. Customer also noted that they observed teflon flaking from the wash head. Field service engineer (fse) inspected the instrument on (b)(4) 2012, and ran 9 repetitions of vigil level 2 and 3 as a baseline. Fse noted that all level 2 repetitions were scattered, and level 3 was more precise but elevated. Fse replaced the wash head and performed all alignments. Fse ran another 9 repetitions of precision study for vigil 2 and 3. Fse noted that all level 2 results were within 1 standard deviation of the assigned mean, and level 3 was still elevated, however, precision had improved slightly. Fse advised customer to re-evaluate the level 3 mean. Fse also ran rf control (level 1biorad) precision study. Fse noted that all repetitions were low, but found that the qc material was over 5 days old. Fse instructed the customer to run the instrument in the morning and call if any issues arise. To date customer has not reported any issues.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2050012-2012-00525
• MDR Report Key: 2461660
• Report Source: 05,06
• Date Received: 2012-02-20
• Date of Report: 2012-01-27
• Date of Event: 2012-01-23
• Date Mfgr Received: 2012-01-27
• Device Manufacturer Date: 1999-09-08
• Date Added to Maude: 2012-08-21
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: MS. DUNG NGUYEN
• Manufacturer Street: 250 SOUTH KRAEMER BOULEVARD
• Manufacturer City: BREA CA 92821
• Manufacturer Country: US
• Manufacturer Postal: 92821
• Manufacturer Phone: 7149614941
• Single Use: 3
• Remedial Action: NO
• Previous Use Code: 3
• Removal Correction Number: 2050012-01/26/2012-003C
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: IMMAGE IMMUNOCHEMISTRY SYSTEM
• Generic Name: NEPHELOMETER, FOR CLINICAL USE
• Product Code: DHR
• Date Received: 2012-02-20
• Model Number: IMMAGE SYSTEM 120V
• Catalog Number: 470000
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BECKMAN COULTER, INC.
• Manufacturer Address: 250 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-02-20