MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-05-26 for ACCESS 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter, Inc..
[2074628]
The customer alleged discordance between access progesterone assay and quest bayer centaur results for one pt involving access 2 immunoassay system. This report refers to sample number one. Three samples from this pt were sent to beckman coulter, inc for further analysis and heterophile interference was confirmed. It is unk if the erroneous results were released out of the laboratory. There was no report of pt injury or change in pt treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[9192084]
Service was not required as the event was isolated to a specific pt sample. Heterophile interference. Samples are drawn in plastic serum tubes with gel separators and are centrifuged for 3000 rpm for greater than 5 minutes. System info and quality control (qc) info was not supplied by the customer. Heterophile interference is the root cause of this event. Product labeling: for assays employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (hama) in the sample. Human anti-mouse antibodies may be present in samples from pts who have received immunotherapy or diagnostic procedures utilizing monoclonal antibodies or in individuals who have been regularly exposed to animals. Additionally, other heterophile antibodies, such as human anti-goat antibodies, may be present in pt samples. This reportable event was identified during a retrospective review of product complaints conducted between january 1, 2008 to october 23, 2010 for additional reportable events. Related mdrs: 2122870-2011-01457 and 2122870-2011-01458.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-01456 |
| MDR Report Key | 2146090 |
| Report Source | 05,06 |
| Date Received | 2011-05-26 |
| Date of Report | 2007-07-02 |
| Date of Event | 2007-06-27 |
| Date Mfgr Received | 2007-07-02 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2011-09-21 |
| 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. 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 DR. |
| 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 |
| Product Code | CGN |
| Date Received | 2011-05-26 |
| Model Number | NA |
| Catalog Number | 81600N |
| 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 | 2011-05-26 |