MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-06-24 for CELL-DYN SMS 05H29-01 manufactured by Abbott Diagnostics Division.
[48192286]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[48192287]
The customer reports that the cell-dyn slide maker stainer (sms) instrument assigned the incorrect patient identification to a prepared blood sample film. The issue could not be recreated. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[54646386]
Instrument log files from the cell-dyn sms (slide maker stainer) were not available from the customer site. From information gathered from the customer, the instrument experienced an issue in its dispensing/rinsing circuit causing some blood from the first sample to remain in the aspiration tubing. It is reasoned that a small amount of air was blocking the tubing and a portion of the first sample remained in the tubing and was not dispensed onto the first slide. The remaining blood was diluted with diluent during the rinsing process. This caused the next sample aspiration to be negatively affected because the sensor detected the presence of the remaining sample in the aspiration circuit. When the dispense cycle for the second sample was performed, the diluted first sample was added to the second slide. The customer could not tell if the blood smear of the second slide is a mixture of the first and second samples. The results of the review of the second slide were not provided. A positive identification could not be determined. An abbott field service engineer (fse) visited the customer site and could not reproduce the issue. However, as a preventive measure, several instrument parts were either cleaned or replaced. Subsequent instrument operations were acceptable. No further issues were noted. 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 operation manual contains information to address the current customer issue. This issue was specific to the individual cell-dyn sms instrument at this specific customer site. Based on the evaluation results and the information from the customer site, there is no evidence to reasonably suggest a product deficiency is present. The issue was addressed through standard troubleshooting procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919069-2016-00768 |
| MDR Report Key | 5749171 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-06-24 |
| Date of Report | 2016-09-09 |
| Date Mfgr Received | 2016-09-08 |
| Device Manufacturer Date | 2000-06-22 |
| Date Added to Maude | 2016-06-24 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 2016-06-24 |
| Catalog Number | 05H29-01 |
| 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 | 2016-06-24 |