MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-27 for FP1000 CELL PREPARATION SYSTEM 624922 manufactured by Beckman Coulter.
[4095598]
A customer reported getting higher cd4+ absolute count values on patient samples processed on their fp1000 cell preparation system, as compared to samples processed on the prep plus ii system. Erroneous results were generated on at least 20 samples. Six erroneous result was reported from the laboratory. These results were part of a larger run and appeared to be intermittent within that run. Impact to patient treatment information has been requested but to date has not been provided. Erroneous results were verified by running the same samples from the prep plus ii system in parallel with a manual addition of antibodies and flow-count and by running samples in parallel on a multiplatform system with a sysmex used to generate total wbc and % lymphocyte values.
Patient Sequence No: 1, Text Type: D, B5
[11531423]
A field service engineer (fse) went on site on (b)(4) 2014. The fse ran verification procedures and gravimetric testing. This testing passed specifications at that time and the fse did not identify an instrument malfunction. The fse replaced the flow count probe (pn (b)(4)) and flow count syringe ((b)(4)) as a presumptive measure. Subsequent correlation studies were performed by the customer and did show that the actions taken by the fse did fix the problem. The results on samples prepared on the fp1000 now do correlate to the results generated for samples prepared on the prep plus. Upon recur, erroneously high cd4+ results may be generated. Physician may be misled during diagnosis or screening of immunocompetence and delay initiation of antiretroviral therapy or treatment for opportunistic infections. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2014-00225 |
| MDR Report Key | 3594149 |
| Report Source | 05,06 |
| Date Received | 2014-01-27 |
| Date of Report | 2014-01-02 |
| Date of Event | 2014-01-02 |
| Date Mfgr Received | 2014-01-02 |
| Device Manufacturer Date | 2011-11-15 |
| Date Added to Maude | 2014-04-22 |
| 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 |
| 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 |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FP1000 CELL PREPARATION SYSTEM |
| Generic Name | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2014-01-27 |
| Model Number | NA |
| Catalog Number | 624922 |
| Lot 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 |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-27 |