MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-08-03 for UNICEL? DXC 600I SYNCHRON? ACCESS? CLINICAL SYSTEM A27318 manufactured by Beckman Coulter, Inc..
[2043889]
The customer reported that erroneously high total bilirubin (tbil) results were generated from a unicel dxc 600i synchron access clinical system for one patient's samples over two days. This report is one of two and represents the erroneously high total bilirubin (tbil) result generated from a unicel dxc 600i synchron access clinical system on (b)(6) 2011 for one patient sample. The initial tbil result was a suppressed value with an "out of instrument range high" instrument flag. Upon repeat testing of a dilution of the sample, the laboratory technician incorrectly calculated the end result. The technician did not follow the calculation instructions provided in a beckman coulter inc. Technical applications letter dated (b)(6) 2007. Due to this error, the reported result was ten times the correct result. The patient was admitted to the hospital. It is unknown as to whether hospital admission was based upon this incorrect result, however for the purposes of this report it is assumed that hospital admission was linked to the erroneous tbil result. A physician questioned the high result and the sample was retested on a diluted sample utilizing the correct calculation to generate the final result. This result was lower, more believable, and regarded as valid. Specific patient information and sample collection/handling information was not supplied by the customer. Instrument tbil quality controls results during the timeframe of the event were found to be within specification.
Patient Sequence No: 1, Text Type: D, B5
[9265562]
User error contributed or caused this event. No service was dispatched to the site for this event. Mdrs associated with this event: 2050012-2011-03822 and 2050012-2011-03823.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-03822 |
| MDR Report Key | 2190005 |
| Report Source | 05,06 |
| Date Received | 2011-08-03 |
| Date of Report | 2011-07-14 |
| Date of Event | 2011-07-13 |
| Date Mfgr Received | 2011-07-14 |
| Device Manufacturer Date | 2010-06-03 |
| Date Added to Maude | 2011-08-04 |
| 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 | 250 S KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXC 600I SYNCHRON? ACCESS? CLINICAL SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY |
| Product Code | JFM |
| Date Received | 2011-08-03 |
| Model Number | NA |
| Catalog Number | A27318 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-08-03 |