MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05,06 report with the FDA on 2012-02-07 for IMMAGE ALPHA-1-ANTITRYPSIN (AAT) 447740 manufactured by Beckman Coulter, Inc..
[9957254]
Evaluation- method/conclusions: device from the same lot was evaluated. The evaluation confirmed the imprecision issue at lower concentrations of aat.
Patient Sequence No: 1, Text Type: N, H10
[19929522]
Customer reported imprecision with the immage alpha-1-antitrypsin (aat) reagent when using the immage 800 immunochemistry system. The imprecision was identified with the quality control samples with lower concentrations of aat. While there were no reports of erroneous patient test results, a similar difference in test results could occur with patient samples. There were no reports of death or serious injury associated with this event. It is unknown if there was any affect to patient treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[20278390]
This issue is under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00339 |
| MDR Report Key | 2440998 |
| Report Source | 02,05,06 |
| Date Received | 2012-02-07 |
| Date of Report | 2012-01-12 |
| Date of Event | 2012-01-12 |
| Date Mfgr Received | 2012-04-03 |
| Device Manufacturer Date | 2011-04-22 |
| Date Added to Maude | 2012-08-14 |
| 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. DUNG NGUYEN |
| Manufacturer Street | 250 S KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| 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 ALPHA-1-ANTITRYPSIN (AAT) |
| Generic Name | ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL |
| Product Code | DEM |
| Date Received | 2012-02-07 |
| Model Number | NA |
| Catalog Number | 447740 |
| Lot Number | M105003 |
| ID Number | NA |
| Device Expiration Date | 2013-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2012-02-07 |