MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-04-21 for CELL-DYN SMS 05H29-04 manufactured by Abbott Diagnostics Division.
[5743787]
The customer reports that a blood film prepared by the cell-dyn sms (ln: 05h29-04) was made from the blood of two different patients. A slide prepared from sample 15p021188 contained many blast cells and was prepared at 13:38. The next slide (sample 15p021147) contained blast cells and prepared at 13:49, which did not fit the patient's clinical condition. At the time, the instrument was generating internal waste full recovery errors, although the collector bottle was not full. The customer believes that the suspect film was due to carryover caused by this error. The customer manually prepared a new slide from sample 15p021147, which did not contain any blast cells. An abbott field service engineer at the site could not recreate the issue. No suspect results were reported from the lab with no patient impact.
Patient Sequence No: 1, Text Type: D, B5
[13159828]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. Date of event and date of report and date received by the manufacturer are due to time zone differences.
Patient Sequence No: 1, Text Type: N, H10
[30230266]
No returns were made available from the customer site for this evaluation. An abbott field service engineer (fse) evaluated the instrument at the customer site. The fse performed a full check and cleaning on the internal waste chamber. All subsequent instrument operations and test results were acceptable. The customer's issue could not be recreated. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. The cell-dyn sms system operator manual contains information to address the current customer issue. Based on the available information from the customer site and from the results of this evaluation, there is no evidence of a product deficiency. The issue was addressed through standard troubleshooting procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919069-2015-00020 |
| MDR Report Key | 4711308 |
| Report Source | 01,05 |
| Date Received | 2015-04-21 |
| Date of Report | 2015-04-01 |
| Date of Event | 2015-04-02 |
| Date Mfgr Received | 2015-06-19 |
| Device Manufacturer Date | 2012-03-06 |
| Date Added to Maude | 2015-05-20 |
| 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 | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT DIAGNOSTICS DIVISION |
| Manufacturer Street | 4551 GREAT AMERICA PARKWAY |
| Manufacturer City | SANTA CLARA CA 95054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELL-DYN SMS |
| Generic Name | AUTOMATED BLOOD FILM PREPARATION AND STAINING |
| Product Code | GKJ |
| Date Received | 2015-04-21 |
| Catalog Number | 05H29-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSTICS DIVISION |
| Manufacturer Address | 4551 GREAT AMERICA PARKWAY SANTA CLARA CA 95054 US 95054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-21 |