MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-16 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM A15445 manufactured by Beckman Coulter, Inc..
[2540768]
The customer contacted beckman coulter, inc. (bec) to report erroneous results for immunoglobulin a (iga), immunoglobulin g (igg), and immunoglobulin m (igm) for six (6) patient samples assayed on an immage 800 immunochemistry system. The erroneous iga, igg, and igm results were not reported outside of the laboratory. There was no impact to patient treatment associated with this event. The customer reported obtaining error messages when assaying some of the patient samples in question. Repeat analyses yielded numerical results. The customer did not provide information regarding which results were considered to be correct and reported outside of the laboratory. The customer provided calibration and quality control data for review which were found to be within acceptable specifications prior to the event. Following the event, calibration and quality control data recovered outside of acceptable specifications. Initial troubleshooting activities were performed by the customer which had failed to resolve the issue. As a result, bec scheduled a service call.
Patient Sequence No: 1, Text Type: D, B5
[9630569]
A field service engineer (fse) was dispatched to the customer's site. The fse observed that the cuvettes in the instrument were overflowing when running a cuvette wash. The fse replaced the wash tower filter. The fse verified the repair per established procedures including running calibrations and assaying quality controls. All results recovered within acceptable specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00433 |
| MDR Report Key | 2456078 |
| Report Source | 05,06 |
| Date Received | 2012-02-16 |
| Date of Report | 2012-01-16 |
| Date of Event | 2012-01-14 |
| Date Mfgr Received | 2012-01-16 |
| Device Manufacturer Date | 2009-07-27 |
| Date Added to Maude | 2012-08-17 |
| 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 |
| 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 | CFN |
| Date Received | 2012-02-16 |
| Model Number | NA |
| Catalog Number | A15445 |
| Lot Number | NA |
| ID Number | SOFTWARE VERSION 2.0 |
| 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 | 2012-02-16 |