MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-06-12 for ACT 5DIFF RINSE 8547167 manufactured by Beckman Coulter.
[3544290]
The customer reported to beckman coulter (bec) obtaining white blood count (wbc) results bias low on all quality control (qc) on the coulter ac t 5diff cp analyzer. The customer technical support (cts) confirmed that the diluent and act 5 diff rinse reagent were replaced the second week of april, and that no calibration adjustments had been completed. No patient samples were run during the time period that the issue with controls was identified up to the time that the instrument underwent repairs, and no erroneous patient results were generated. There was no change or effect to patient treatment in relation to this event. This mdr is to report the event occured on (b)(6) 2013. Please refer to mdr 1061932-2013-01146 which covers the event occurred on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
[10782303]
A beckman coulter field service engineer (fse) was dispatched to the customer site. The fse replaced multiple hardware components; however, it did not resolve the problem. Upon further inspection, the fse discovered the instrument was running with a contaminated act 5diff reagent with an open container expiration date of 07/18/2013. Per the fse, the reagent had visible gross white precipitate inside the bottle. The fse cleaned the system and replaced the reagent with a new bottle (lot number 13002c00357) with product closed container expiration date of 12/27/2013, resolving the control recovery issue. Failure mode related to the low wbc vote outs and low wbc results on controls was related to a contaminated act 5 diff rinse reagent bottle. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2013-00958 |
| MDR Report Key | 3166309 |
| Report Source | 05,06 |
| Date Received | 2013-06-12 |
| Date of Report | 2013-04-29 |
| Date of Event | 2013-04-29 |
| Date Mfgr Received | 2013-04-29 |
| Device Manufacturer Date | 2012-12-27 |
| Date Added to Maude | 2013-09-09 |
| 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 CULTER |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACT 5DIFF RINSE |
| Generic Name | DETERGENT |
| Product Code | JCB |
| Date Received | 2013-06-12 |
| Model Number | NA |
| Catalog Number | 8547167 |
| Lot Number | 13002C00352 |
| ID Number | NA |
| Device Expiration Date | 2013-12-27 |
| 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 | 2013-06-12 |