MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-06-22 for UNICEL DXI 800 ACCESS? IMMUNOASSAY SYSTEM N/A A71456 manufactured by Beckman Coulter Inc..
[2728798]
The customer reported one occurence of a non-reproducible false positive creatinine kinase (ck-mb) results for two patients which was generated from a unicel dxi 800 access immunoassay system. This report is for one of the two patients involved in the event. Please see medwatch #2122870-2012-01536 for the report on the other patient. The customer stated that repeat results on the original and alternate dxi 800 analyzer recovered within the normal reference range of the assay. The false positive result was released from the laboratory and an amended report was filed after receiving the repeat results. The customer stated that the patient was dismissed from the hospital and does not believe that there was injury or change to patient treatment. The customer noted that the sample was from the automation line and spun at ambient temperature for 4 minutes at 3000 rounds per minute. The customer stated that the repeat was done by front loading the sample onto the dxis and run on primary tube. The sample tube was approximately half full but the customer was unaware of how full the sample was when originally run. The customer did not note any fibrin or other issues with the samples during repeat run. The customer stated that quality control (qc) samples run before and after the incident were within the laboratory's established limits but declined to provide event-specific qc data. Beckman coulter field service engineer (fse) was dispatched and performed a high sensitivity system check. All parameters passed within specifications and no hardware issues were found. The system was verified as performing to published performance specifications and cause for this event could not be determined. Ck-mb reagent lot 118711 and calibrator lot 119344 were used in conjunction with the dxi 800 analyzer for this event.
Patient Sequence No: 1, Text Type: D, B5
[10114615]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-01510 |
| MDR Report Key | 2626821 |
| Report Source | 05,06 |
| Date Received | 2012-06-22 |
| Date of Report | 2012-06-05 |
| Date of Event | 2012-05-29 |
| Date Mfgr Received | 2012-06-05 |
| Device Manufacturer Date | 2012-01-30 |
| Date Added to Maude | 2012-10-10 |
| 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. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL DXI 800 ACCESS? IMMUNOASSAY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2012-06-22 |
| Model Number | N/A |
| Catalog Number | A71456 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-06-22 |