MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-04-02 for ACCESS? IMMUNOASSAY SYSTEM R81600 manufactured by Beckman Coulter Inc..
[1301180]
A customer obtained lower than expected results for progesterone on two (2) patients' samples. A) the results were reported out of the lab. B) one patient was treated with progesterone and subsequent testing still resulted low. C) the second patient's sample was tested on an alternate method and recovered higher results that fit the patient's clinical picture.
Patient Sequence No: 1, Text Type: D, B5
[8589777]
Sample collection and system performance information was not supplied. Service was not dispatched for this event. A malfunction will be assumed for the purpose of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2010-00120 |
| MDR Report Key | 1649346 |
| Report Source | 05 |
| Date Received | 2010-04-02 |
| Date of Report | 2010-04-02 |
| Date of Event | 2010-02-25 |
| Date Mfgr Received | 2010-03-04 |
| Device Manufacturer Date | 2000-03-17 |
| 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 | ACCESS? IMMUNOASSAY SYSTEM |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | MXZ |
| Date Received | 2010-04-02 |
| Model Number | ACCESS? IMMUNOASSAY SYSTEM |
| Catalog Number | R81600 |
| 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 | 2010-04-02 |