MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-01 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM IMMAGE 800 A15445 manufactured by Beckman Coulter, Inc..
[2555814]
Customer reported erroneous low test results for igg (immunoglobulin g), iga (immunoglobulin a), igm (immunoglobulin m), kappa and lambda were obtained for one patient sample when using the immage 800 immunochemistry system. The erroneous test results were not reported out of the laboratory. Quality control data provided by the customer demonstrated imprecision. There were no reports of death, serious injury or affect to patient treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[9623078]
A beckman coulter field service engineer (fse) evaluated the analyzer and replaced the sample probe. The fse performed sample crane alignments, verified both syringes and cuvettes, and ran multiple patient samples and quality control. The probable cause of this event was attributed to a malfunction of the sample probe. This mdr is one of two events reported by this customer. The related mdr is 2050012-2012-00338.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00337 |
| MDR Report Key | 2433960 |
| Report Source | 05,06 |
| Date Received | 2012-02-01 |
| Date of Report | 2012-01-11 |
| Date of Event | 2012-01-09 |
| Date Mfgr Received | 2012-01-11 |
| Device Manufacturer Date | 2007-12-19 |
| Date Added to Maude | 2012-08-10 |
| 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 | 0 |
| 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 | CFF |
| Date Received | 2012-02-01 |
| Model Number | IMMAGE 800 |
| Catalog Number | A15445 |
| Lot Number | NA |
| ID Number | NA |
| 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 | 2012-02-01 |