MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-07 for IMMAGE? IMMUNOCHEMISTRY SYSTEM 470000 manufactured by Beckman Coulter, Inc..
[15147135]
The customer reported that on (b)(6) 2011, erroneous prealbumin (pab) and/or transferrin (trf) results were generated on an immage immunochemistry system for multiple patient samples. The exact number of involved patient samples in unknown. Although the customer indicated that immunoglobulin g (igg) and c-reactive protein (crp) quality control results were discrepant, the customer did not indicate or provide evidence that any igg and crp patient results were affected. Data provided by the customer indicated the generation of eleven pab results and two trf results. No evidence of discrepant immunoglobulin g (igg) and c-reactive protein (crp) results was provided. In seven cases, the repeat pab results were lower and regarded valid. In both cases, the repeat trf results were lower and considered valid. In one case, the repeat pab result was higher than the initial pab result. In three cases the pab initial results was not repeated and hence the initial results were not confirmed as erroneous by repeat testing. The erroneous initial results were not reported out of the laboratory and hence there were no deaths, serious injuries or change to patients' treatment associated or attributed to this event. Samples were serum. Pab, trf, igg and crp quality control (qc) results during the timeframe of the event were "high" upon initial run as well as on a rerun attempt after implementing new reagent packs and controls. After priming the instrument, all assay qc results were within established ranges.
Patient Sequence No: 1, Text Type: D, B5
[15168308]
Service was dispatched to the site on (b)(4) 2011, for this event. The fse replaced the reagent probe, sample probes and level sense boards for probes. The fse replaced the mixer paddles, and cuvette wash head. After the repairs, the fse performed instrument performance verification assessments which met specifications. Mdr associated with this event: 2050012-2011-02578, 2050012-2011-04955.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-04955 |
| MDR Report Key | 2235848 |
| Report Source | 05,06 |
| Date Received | 2011-09-07 |
| Date of Report | 2011-08-09 |
| Date of Event | 2011-08-09 |
| Date Mfgr Received | 2011-08-09 |
| Device Manufacturer Date | 2001-02-27 |
| Date Added to Maude | 2012-05-25 |
| 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 NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| 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 | JNM |
| Date Received | 2011-09-07 |
| Model Number | NA |
| 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 | 2011-09-07 |