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..
[2213329]
The customer reported that erroneous haptoglobin (hpt) and microalbumin (ma) results were generated on an immage immunochemistry system over two days. This report is one of two and represents the erroneous ma patient results generated on (b)(4) 2011. Beckman coulter inc. Assessment of customer supplied data indicated that seven patient elevated, erroneous ma results were generated. Instrument flags were generated for elevated results and for one suppressed result. Data indicated that initial samples were repeated for two patients and generated the same results upon repeat. Additionally the customer indicated that two repeat results of 69 and 29 mg/dl were generated, but it is unknown to which initial results these repeat results were linked. Patient reports were amended. 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 ma samples were random urine 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
[9432027]
Service was dispatched to the site on (b)(4) 2011, for this event. The field service engineer (fse) replaced the sample and reagent syringes and replaced a flaking teflon wash head. The fse replaced a bent sample mixer paddle and flushed the sample and 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 | 2050012-2011-06151 |
| MDR Report Key | 2289187 |
| Report Source | 05,06 |
| Date Received | 2011-10-12 |
| Date of Report | 2011-09-19 |
| Date of Event | 2011-09-16 |
| 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 |