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..
[2115209]
The customer contacted beckman coulter, inc. (bci) on (b)(6) 2008 in regards to erroneously elevated accutni results generated on the access 2 immunoassay system for eleven patients. The patient samples were retested and the results were within the normal reference range. The initial erroneously elevated results were reported outside the laboratory. It is not known if there was any change to the patient treatment. There is no indication of an adverse event or indication of any medical intervention to prevent serious injury. This report refers to patient number nine.
Patient Sequence No: 1, Text Type: D, B5
[9166736]
Service was not dispatched for this event. The quality control (qc) data for (b)(6) 2008 and (b)(6) 2008 provided by the customer was reviewed. This review did not indicate any abnormalities and all information was within specification. The system checks data that was performed on (b)(6) 2008 and (b)(6) 2008 was reviewed and it was within instrument specifications. Following this event, bci sent a new reagent lot to the customer to conduct correlation studies at the user site. Patient correlation studies were performed by the customer and the results were within expected range for all products. No definitive root cause can be determined for this event. This is three of eleven separate mdr reports related to eleven patients event associated with a single malfunction report. Reference mdr numbers 2122870-2011-01485, 2122870-2011-01486. 2122870-2011-01488, 2122870-2011-01489, 2122870-2011-01490, 2122870-2011-01490, 2122870-2011-01491, 2122870-2011-01492, 2122870-2011-01494, 2122870-2011-01495 for all related events. This reportable event was identified during a retrospective review of complaints conducted between (b)(4) 2008 and (b)(4) 2010 for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-01493 |
| MDR Report Key | 2142177 |
| Report Source | 05,06 |
| Date Received | 2011-05-26 |
| Date of Report | 2008-12-30 |
| Date of Event | 2008-12-28 |
| Date Mfgr Received | 2008-12-30 |
| Device Manufacturer Date | 2001-02-01 |
| 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 | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DR. CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-26 |