MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-06-17 for IMMAGE IMMUNOCHEMISTRY SYSTEM 470000 manufactured by Beckman Coulter Inc..
[2052473]
A customer contacted beckman coulter inc. (bci) in regards to erroneous high prealbumin (pab) results generated by the immage immunochemistry system. The results were reported out of the laboratory. The samples were repeated and lower results were obtained. Patient treatment was not impacted by this event.
Patient Sequence No: 1, Text Type: D, B5
[9018139]
Sample information was not provided. Calibration results from (b)(4) 2011 were acceptable. Qc results on (b)(4) 2011 were out of range high for igg and pab for level 1. Repeat testing brought the results back within range. No other chemistry issues or system errors were noted. On (b)(4) 2011 a bci field service engineer (fse) inspected the instrument and noted qc is working properly. No signs of hardware issues were noted. Advised the customer to run pab qc at the start of the day and at the end f the patient run. No additional issues were reported or noted. Issue was resolved by recalibrating.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-02264 |
| MDR Report Key | 2132116 |
| Report Source | 06 |
| Date Received | 2011-06-17 |
| Date of Report | 2011-05-17 |
| Date of Event | 2011-05-14 |
| Date Mfgr Received | 2011-05-17 |
| Device Manufacturer Date | 2011-02-27 |
| Date Added to Maude | 2012-02-27 |
| 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 | 0 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER/IMMUNOCHEMISTRY SYSTEMS |
| Product Code | JQX |
| Date Received | 2011-06-17 |
| Model Number | IMMAGE |
| Catalog Number | 470000 |
| Lot Number | N/A |
| ID Number | N/A |
| 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 | 2011-06-17 |