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 2011-12-01 for ACCESS IMMUNOASSAY SYSTEM R81600 manufactured by Beckman Coulter, Inc..
[2275071]
The customer contacted beckman coulter, inc (bec) to report an erroneous progesterone pt sample result generated on their access immunoassay system. The erroneous pt sample result was reported outside of the laboratory. Based on the erroneous pt sample result, the physician administered progesterone to the pt. When the physician ordered a subsequent progesterone test, the result was unexpectedly low. The physician suspected a discrepancy between the clinical presentation of the pt and the progesterone result. System check and quality control data have not been provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
[9495402]
A field service engineer (fse) was not dispatched to the customer's site. A definitive root cause for this event has not been determined. This reportable event was identified during a retrospective review conducted between january 1, 2008 and october 23, 2010 of complaints for add'l reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-05723 |
| MDR Report Key | 2356054 |
| Report Source | 01,05,06 |
| Date Received | 2011-12-01 |
| Date of Report | 2010-03-04 |
| Date of Event | 2010-02-25 |
| Date Mfgr Received | 2010-03-04 |
| Device Manufacturer Date | 2000-03-01 |
| Date Added to Maude | 2011-12-05 |
| 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 |
| Product Code | MXZ |
| Date Received | 2011-12-01 |
| Model Number | NA |
| Catalog Number | R81600 |
| Lot Number | NA |
| ID Number | NA |
| 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 | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-01 |