MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-10-07 for COULTER SCATTER PAK REAGENT KIT 8546917 manufactured by Beckman Coulter Australia Pty Ltd.
[2231073]
Customer reported an increase in the flag for increased basophils (basophilia) was occurring on the coulter gen-s system. The increase was identified when comparing test results obtained with the coulter hmx hematology analyzer. The customer performed a slide review to determine if basophilia was present in the pt samples. No erroneous test results were reported. The problem was resolved when the reagent lot of the coulter scatter pak reagent kit was replaced. No reports of death or serious injury, and no affect to pt treatment as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[9372024]
The customer reported that controls recovered within expected ranges. The event was corrected by installation of a replacement lot of coulter scatter pak reagent kit on the system. This is the only reported event for the lot number a070910. Personnel from the mfg site in (b)(4) reviewed the event and indicated that it was possible that the affected lot may have been exposed to elevated temperatures during transportation and/or product storage. This was determined to be the probable cause of the event. This reportable event was identified during a retrospective review conducted between 01/01/2008 and 10/23/2010 of complaints for add'l reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01594 |
| MDR Report Key | 2320147 |
| Report Source | 01,05,06 |
| Date Received | 2011-10-07 |
| Date of Report | 2008-02-22 |
| Date of Event | 2008-02-22 |
| Date Mfgr Received | 2008-02-22 |
| Device Manufacturer Date | 2007-09-01 |
| Date Added to Maude | 2012-06-29 |
| 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 AUSTRALIA PTY LTD |
| Manufacturer Street | 24 COLLEGE ST |
| Manufacturer City | GLADESVILLE NSW2111 |
| Manufacturer Country | AS |
| Manufacturer Postal Code | NSW 2111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER SCATTER PAK REAGENT KIT |
| Product Code | GGK |
| Date Received | 2011-10-07 |
| Model Number | NA |
| Catalog Number | 8546917 |
| Lot Number | A070910 |
| ID Number | NA |
| Device Expiration Date | 2008-06-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER AUSTRALIA PTY LTD |
| Manufacturer Address | 24 COLLEGE ST GLADESVILLE NSW2111 AS NSW 2111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-07 |