MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-30 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM A15445 manufactured by Beckman Coulter, Inc..
[3051978]
The customer reported erroneous immunoglobulin m (igm) results, for one patient, on separate days, involving immage 800 immunochemistry system. This is report one of two. The original sample produced a result of 168 mg/dl. Subsequent analysis of the sample, at a reference laboratory, produced an igm value of 4,000 mg/dl. The customer reanalyzed the sample in the laboratory and recovered a result of 3,830 mg/dl. Patient history indicated the patient had previous igm results of 3,910, 3,900, and 4,000 mg/dl. The erroneous result was released out of the laboratory. There was no report of patient consequence or change in patient treatment associated with this event. The customer indicated there were no hardware issues. Calibration and quality control (qc) results were within the established ranges prior to the event. Beckman coulter field service engineer (fse) went to the facility and assessed the instrument.
Patient Sequence No: 1, Text Type: D, B5
[10035737]
The field service engineer (fse) noted black coating worn off the cuvette wash head which clogged the filter, with rust build-up. The fse replaced the cuvettes, wash head, and in-line filter, due to cloudy and dirty cuvettes, and resolved the issue. The fse noted clog and build-up were due to lack of cleaning and rinsing within the system. The instrument conformed to the manufacturer's published performance specifications. Cuvette, wash head. This medwatch report is related to 2050012-2012-01708.
Patient Sequence No: 1, Text Type: N, H10
[11188591]
Additional information: upon further investigation, beckman coulter has determined that there are no critical chemistries analyzed on the immage 800 immunochemistry system. Upon recur, the malfunction would not cause or contribute to a serious injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01709 |
| MDR Report Key | 2721970 |
| Report Source | 05,06 |
| Date Received | 2012-08-30 |
| Date of Report | 2012-08-02 |
| Date of Event | 2012-07-23 |
| Date Mfgr Received | 2013-08-07 |
| Device Manufacturer Date | 2009-03-02 |
| Date Added to Maude | 2012-12-17 |
| 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, 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 | IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER, FOR CLINICAL USE |
| Product Code | DAO |
| Date Received | 2012-08-30 |
| Model Number | NA |
| Catalog Number | A15445 |
| Lot Number | NA |
| ID Number | SOFTWARE VERSION 2.0 |
| 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 | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-30 |