MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-03-30 for UNICEL? DXI 800 ACCESS? IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter Inc..
[1338932]
A customer obtained lower than expected results for progesterone for one patient. One sample was repeated on a different reagent lot and progesterone results recovered much higher, within a different diagnostic reference range. The results were reported out of the lab. Based on available information, the patient was given an injection of progesterone due to the lower than expected progesterone results.
Patient Sequence No: 1, Text Type: D, B5
[8594375]
Sample collection, qc, and maintenance information was not supplied. A field service engineer (fse) was not dispatched for this event. A definitive root cause for this event has not been determined. A malfunction will be assumed for the purpose of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2010-00119 |
| MDR Report Key | 1644240 |
| Report Source | 05 |
| Date Received | 2010-03-30 |
| Date of Report | 2010-03-30 |
| Date of Event | 2010-02-12 |
| Date Mfgr Received | 2010-02-18 |
| Device Manufacturer Date | 2005-04-11 |
| Date Added to Maude | 2010-08-10 |
| 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. 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 | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXI 800 ACCESS? IMMUNOASSAY SYSTEM |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | MXZ |
| Date Received | 2010-03-30 |
| Model Number | NA |
| Catalog Number | 973100 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-30 |