MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-12 for IMMAGE? IMMUNOCHEMISTRY SYSTEM A15445 manufactured by Beckman Coulter, Inc..
[2212813]
The customer reported that erroneous haptoglobin (hpt) and microalbumin (ma) results were generated on an immage immunochemistry system over two days. This report is two of two and represents the erroneous hpt patient results generated on (b)(6) 2011. Beckman coulter inc. Assessment of customer supplied data indicated that three patients experienced erroneous, low hpt results. Instrument flags were generated for low results. No confirmatory repeat testing results were provided for these patients. Unrelated chemistry results were also provided that were not questioned by the customer as discrepant. The erroneous results were reported out of the laboratory however there was no death, serious injury or change to patient treatment associated or attributed to this event. The hpt samples were serum samples. No sample issues were noted. Instrument chemistry quality control (qc) results were within the customer's established specification during the timeframe of the event. No other system errors or issues with other chemistries were noted.
Patient Sequence No: 1, Text Type: D, B5
[9431561]
Service was dispatched to the site on (b)(6) 2011 for this event. The field service engineer (fse) replaced the sample & reagent syringes and replaced a flaking teflon wash head. The fse replaced a bent sample mixer paddle and flushed the sample & reagent probes. The fse then performed all necessary alignments. Upon completion of the necessary and verified repairs, the instrument was returned into operation. While the hardware repairs performed appear to have resolved the issue, a definitive root cause has not been determined to date for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-06153 |
| MDR Report Key | 2289157 |
| Report Source | 05,06 |
| Date Received | 2011-10-12 |
| Date of Report | 2011-09-19 |
| Date of Event | 2011-09-19 |
| Date Mfgr Received | 2011-09-19 |
| Device Manufacturer Date | 2010-08-17 |
| Date Added to Maude | 2012-06-14 |
| 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 | 2011-10-12 |
| Model Number | NA |
| 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 | 2011-10-12 |