MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-09-06 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM A15445 manufactured by Beckman Coulter, Inc..
[2995981]
The customer reported that erroneous albumin (alb) and cardiac c-reactive protein (ccrp) results without instrument generated flagging were generated on an immage 800 immunochemistry system for four patients. Actual patient results were not provided by the customer. The erroneous patient results were found to be in conjunction with the overflowing of a sample wash station. The leak was not contained within the instrument and had dripped down onto the cabinet and floor. The volume of the leak was approximately forty to fifty milliliters. The customer verbally indicated that one patient's initial alb value was 300 mg/dl prior to discovery of the leak and recovered at 400 mg/dl upon retest after the leak had been resolved. Another patient sample had a ccrp value of <0. 4 mg/dl prior to discovery of the leak and when retested following correction of the leak the value was 0. 5 mg/dl. These results were regarded as outside the precision claims of the assay. No information was provided regarding the other two patients' results. The erroneous alb and ccrp patient results were reported outside of the laboratory however there were no reports of death, serious injury or modification to patient treatment associated or attributed to this event. No error messages were observed prior to discovery of the event. The customer indicated that assay quality control (qc) results met specifications prior to the event. The healthcare worker interfacing with the machine was wearing personal protective equipment which included a laboratory coat, eye protection and gloves. There was no exposure to healthcare worker uncovered wounds or mucous membranes and no injury was reported. No personnel sought any medical attention in association with this event. No death or injury was associated with this event. There was an exposure plan in place at the facility.
Patient Sequence No: 1, Text Type: D, B5
[10133241]
Service was dispatched to the site to address this event. The field service engineer (fse) found that the sample probe wash cup was only partially draining. The fse replaced a specific in line filter which resolved the issue. The instrument was returned back into operation upon the completion of the necessary and verified repairs. The cause of the overflowing sample wash station was a specific probe rinse filter
Patient Sequence No: 1, Text Type: N, H10
[11114812]
Additional information: upon further investigation, beckman coulter has determined that there are no critical chemistries analyzed on the immage 800 immunochemistry system. Upon recur, the malfunction would not cause or contribute to a serious injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01710 |
| MDR Report Key | 2731227 |
| Report Source | 05,06 |
| Date Received | 2012-09-06 |
| Date of Report | 2012-08-17 |
| Date of Event | 2012-08-17 |
| Date Mfgr Received | 2013-08-07 |
| Device Manufacturer Date | 2012-02-29 |
| Date Added to Maude | 2012-12-19 |
| 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? 800 IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER, FOR CLINICAL USE |
| Product Code | NQD |
| Date Received | 2012-09-06 |
| Model Number | NA |
| Catalog Number | A15445 |
| Lot Number | NA |
| ID Number | SOFTWARE VERSION 2.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2012-09-06 |