MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-28 for AU400 CLINICAL CHEMISTRY ANALYZER N1254400 manufactured by Beckman Coulter, Inc..
[3050881]
The customer reported that an erroneous low creatinine kinase (ck) result without instrument flags was generated from an au400 clinical chemistry analyzer for one patient on (b)(6) 2012. The customer had indicated that the initial ck result recovered at a value of 44 u/l. The initial, erroneous result was reported outside the laboratory; however, there was no death, serious injury or modification to patient treatment associated with this event. The customer questioned the initial result due to "it being lower" than what they expected. The patient had a previous sample yielding a much higher ck result. The sample was repeated with a result of 418 u/l, which was in line with customer expectations, and within the normal reference range for the analyte. The customer indicated that quality control results during the timeframe of this event were within established specifications. There were no visual abnormalities identified with the specimen. Specific patient information, additional system performance information and additional sample collection handling information was not provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
[10215935]
Service was not dispatched to the site for this event. The customer cancelled the service request. There have been no further reports of erroneous results from this customer to date. Beckman coulter inc. Assessment of customer supplied instrument performance data indicated that the erroneous results could be attributed to either a sample dispense or r2 dispense issue. The failure mode for this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01687 |
| MDR Report Key | 2718080 |
| Report Source | 05,06 |
| Date Received | 2012-08-28 |
| Date of Report | 2012-08-06 |
| Date of Event | 2012-08-05 |
| Date Mfgr Received | 2012-08-06 |
| Device Manufacturer Date | 2002-09-06 |
| Date Added to Maude | 2012-12-13 |
| 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 DUNG NGUYEN |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER MISHIMA K.K. |
| Manufacturer Street | 454-32 HIGASHINO,NAGAIZUMI-CHO SUNTO-GUN |
| Manufacturer City | SCHIZUOKA, P-NOTA 411-0931 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 411-0931 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AU400 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2012-08-28 |
| Model Number | NA |
| Catalog Number | N1254400 |
| Lot Number | NA |
| ID Number | SOFTWARE VERSION 8.3 |
| 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 | 2012-08-28 |