MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-06-26 for ACT 5DIFF RINSE 8547167 manufactured by Beckman Coulter.
[15771356]
The customer reported to beckman coulter (bec) a transfer sensor time out error message on the coulter act 5diff cp analyzer. The customer indicated that the issue was not resolved by routine cleaning and troubleshooting procedures. The customer was also experiencing no white blood count (wbc) results. Review of the instrument? S reagent log indicates that the act 5 rinse reagent lot number 12802c00022 was loaded in the instrument on (b)(4) 2013 and was replaced by a different lot, 12902c01655, on the same day as the customer was troubleshooting the wbc results of 0. 0. Per conversation with the customer, wbc sample results were at 0. 0 shortly after the act 5 rinse reagent replacement. Customer sent all affected samples to a reference laboratory for confirmation and results from the reference laboratory were reported out as correct. Print outs were requested for review but were not provided. The operator was wearing a laboratory coat and gloves and eye glasses at the time of the incident. There was no biohazard exposure to open wounds or mucous membranes. No erroneous results were reported out of the laboratory and there was no effect to patient treatment in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
[15875185]
A beckman coulter field service engineer (fse) was dispatched to the customer site. The fse confirmed the transfer sensor time out error along with no white blood count (wbc) results. The fse found that a contaminated bottle of act 5 diff rinse reagent had been on the instrument. The fse stated that the reagent bottle appeared to have a "white slime" inside the reagent. The fse thoroughly decontaminated the rinse pickup tube and reagent lines with a bleach solution, and placed a fresh bottle of rinse reagent (lot number 13302c0327) on the instrument. The fse also bleached the differential sample pathway through valves (vl's 4 and 5). After multiple primes, the fse performed a startup procedure and cycled controls with no further issues; results met published performance specifications. Per phone conversation with the customer on (b)(6) 2013, there have been no further problems. The replacement of the contaminated reagent resolved the transfer sensor error and the wbc vote outs issue. Reagent log information was requested and has not yet been received. Failure mode was related to a contaminated act5 rinse reagent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2013-01172 |
| MDR Report Key | 3191488 |
| Report Source | 05,06 |
| Date Received | 2013-06-26 |
| Date of Report | 2013-06-01 |
| Date of Event | 2013-05-31 |
| Date Mfgr Received | 2013-06-01 |
| Device Manufacturer Date | 2012-11-13 |
| Date Added to Maude | 2013-09-18 |
| 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 | 2013-06-26 |
| Model Number | NA |
| Catalog Number | 8547167 |
| Lot Number | 12802C00022 |
| ID Number | NA |
| Device Expiration Date | 2013-11-13 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2013-06-26 |