MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-01 for IMMAGE? IMMUNOCHEMISTRY SYSTEM 470000 manufactured by Beckman Coulter, Inc..
[2070095]
The customer reported that on (b)(6) 2011 erroneous, high prealbumin (pab) results were generated on an immage immunochemistry system for three patient samples. Subsequent repeat pab results were lower, either being within or below normal reference range. The erroneous results were not reported out of the laboratory and hence there were no deaths, serious injuries or change to patients' treatment associated or attributed to this event. Samples were serum. Pab quality control (qc) results during the timeframe of the event were within established specification range and assay calibration results prior to the event met specification. There were no other chemistry or system errors at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
[9282660]
Service was dispatched to the site for this event. The field service engineer (fse) replaced the cuvettes, cuvette wash station, reagent probe motor, reagent arm and performed necessary instrument alignments. Although the fse repaired the instrument prior to returning it into service, a root cause for this event cannot be determined to date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-02578 |
| MDR Report Key | 2147677 |
| Report Source | 05,06 |
| Date Received | 2011-07-01 |
| Date of Report | 2011-06-09 |
| Date of Event | 2011-06-09 |
| Date Mfgr Received | 2011-06-09 |
| Device Manufacturer Date | 2001-02-27 |
| Date Added to Maude | 2012-03-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE? IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER, FOR CLINICAL USE |
| Product Code | JQX |
| Date Received | 2011-07-01 |
| Model Number | NA |
| Catalog Number | 470000 |
| Lot Number | NA |
| ID Number | NA |
| 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 S KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-01 |