MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-17 for IMMAGE? IMMUNOCHEMISTRY SYSTEM 470000 manufactured by Beckman Coulter, Inc..
[19927027]
The customer reported that on (b)(6) 2011 erroneous, high prealbumin (pab) results were generated on an image immunochemistry system. Data supplied from the customer indicated the generation of erroneous pab results for two patient samples upon initial testing. Subsequent multiple repeat tests of the samples were performed on the same instrument. One sample retest for each patient involved a diluted (1:36 dilution ratio) sample. Retest results were lower and considered valid. One patient's initial result required an amended report to be issued. The erroneous results were reported out of the laboratory however there were no reports of death, serious injury or change to patient treatment associated or attributed to this event. Samples were serum. Quality control (qc) results were elevated during the timeframe of the event, and pab assay failed system calibration assessments due to precision issues.
Patient Sequence No: 1, Text Type: D, B5
[20045379]
Service was dispatched on (b)(6) 2011. The field service engineer replaced the sample and reagent probes and three-way valves. The wash head was inspected. The sample and syringe drive were lubricated. Quality control results after repairs passed established specifications, and the instrument was subsequently returned into service. Although repairs were made, a definitive root cause for this event has not been determined to date. Previously reported events associated with this issue include: 2050012-2011-02264, 2050012-2011-02349.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-02389 |
| MDR Report Key | 2132932 |
| Report Source | 05,06 |
| Date Received | 2011-06-17 |
| Date of Report | 2011-05-31 |
| Date of Event | 2011-05-28 |
| Date Mfgr Received | 2011-05-31 |
| Device Manufacturer Date | 2001-02-27 |
| Date Added to Maude | 2012-02-24 |
| 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 | JQX |
| Date Received | 2011-06-17 |
| 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 | 2011-06-17 |