MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-01-31 for ACCESS? 2 IMMUNOASSAY SYSTEM 973111R manufactured by Beckman Coulter, Inc..
[20734326]
The customer reported that progesterone results, discrepant to patient clinical diagnosis, had been obtained from an access 2 immunoassay system for an unspecified number of normal, pregnant or in-vitro fertilization patients' samples. The progesterone results were reported out of the laboratory and it is unknown if there was patient injuries requiring medical intervention or change to patient treatment due to these discrepancies. The samples were collected in serum tubes. Beckman coulter inc. Assessment of supplied data indicates that there may have been bias between collection tube manufacturers. It is unknown as to whether the data provided by the customer was associated with actual, reported patient results or rather investigatory data. No quality control (qc) data was supplied by the customer with the exception of correlation data. This data did not supply details of the customer's day to day qc recovery. No patient information, additional system information, additional sample collection/handling information or patient results were provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
[20907206]
Beckman coutler inc. Service was dispatched to the site and confirmed the system was operating within specifications. No cause for this event has been determined to date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-00171 |
| MDR Report Key | 2433805 |
| Report Source | 01,05,06 |
| Date Received | 2012-01-31 |
| Date of Report | 2012-01-05 |
| Date of Event | 2012-01-05 |
| Date Mfgr Received | 2012-01-05 |
| Date Added to Maude | 2012-07-30 |
| 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 | 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? 2 IMMUNOASSAY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY |
| Product Code | JLS |
| Date Received | 2012-01-31 |
| Model Number | NA |
| Catalog Number | 973111R |
| 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 | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-31 |