MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-03 for IMMAGE? IMMUNOCHEMISTRY SYSTEM 470000 manufactured by Beckman Coulter, Inc..
[17558055]
Customer reported erroneous low test results for c-reactive protein (crp) and immunoglobulin g (igg) were obtained when using the immage immunochemistry system. The test results were higher upon retest. Both assays were calibrated before and after the event. Quality control was within range before and after the event. The erroneous test results were reported out of the laboratory. Amended reports were issued. There were no reports of death, serious injury or affect to patient management associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[17708712]
The customer checked the cuvettes for cleanliness and checked the probes and syringes for leaks or bubbles. The customer also checked the cuvette wash head for signs of teflon peeling, no issues were found. On (b)(4) 2012, a beckman coulter field service engineer identified that the mixer paddles were dirty and replaced them. Reagent probe was also replaced for increased occurrence of level sense errors. Quality control was performed and was within range. Probable cause was determined to be either the mixer paddles or the reagent probe. As of (b)(4) 2012, there were no further reports of this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00336 |
| MDR Report Key | 2438310 |
| Report Source | 05,06 |
| Date Received | 2012-02-03 |
| Date of Report | 2012-01-11 |
| Date of Event | 2012-01-11 |
| Date Mfgr Received | 2012-01-11 |
| Device Manufacturer Date | 2001-02-27 |
| Date Added to Maude | 2012-08-13 |
| 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, 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? IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER, FOR CLINICAL USE |
| Product Code | NQD |
| Date Received | 2012-02-03 |
| Model Number | IMMAGE |
| Catalog Number | 470000 |
| 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 | 2012-02-03 |