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 2011-05-23 for ACCESS? 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter, Inc..
[2003214]
The customer reported that on (b)(6) 2011 a creatine kinase-mb isoenzyme (ck-mb) result above the normal reference range was generated on the access 2 immunoassay system for one patient sample. The patient was an already admitted hospital patient. The result was reported out of the laboratory. The patient was transferred to the intensive care unit (icu) based upon the erroneously elevated ck-mb result. A retest of the sample on (b)(6) 2011, on the same instrument, generated a lower ck-mb value that was considered valid. Quality control results were performing within customer established ranges at the time of the event and system checks were meeting established specifications. The customer has indicated that all other results generated during the timeframe of this event were regarded as valid. The event log during the time of this event indicates that a "status controller initialization error" (which is an error detected while the status controller is initializing the instrument parameters) was generated on the instrument. The nature of this error suggests that it did not occur during patient testing. A service call involving a hard disk error was received from this customer on (b)(4) 2011. The involvement of this error in relation to this event is unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
[8981631]
The classification product code of the suspect medical device involved was incorrectly identified as cgn in the original 3500a. The correct classification product code is jje. The original outcome was incorrectly referenced as "life threatening" and "hospitalization". The correct reference is "hospitalization" and "required intervention".
Patient Sequence No: 1, Text Type: N, H10
[9050356]
Service was not dispatched for this event. An investigation is underway to attempt to determine the root cause of this event. To date, no clear root cause has been determined. The mdr associated with this event consist of: 2122870-2011-01531.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-01539 |
| MDR Report Key | 2099953 |
| Report Source | 01,05,06 |
| Date Received | 2011-05-23 |
| Date of Report | 2011-04-29 |
| Date of Event | 2011-04-27 |
| Date Mfgr Received | 2011-04-29 |
| Device Manufacturer Date | 2005-09-09 |
| Date Added to Maude | 2011-05-24 |
| 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 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 (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JHS |
| Date Received | 2011-05-23 |
| 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 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2011-05-23 |