MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-16 for SMARTCYCLER MINI-CENTRIFUGE 441269 manufactured by Cepheid.
[4382397]
Customer reported that their mini-centrifuge used with their smartcycler instrument continues to spin when lid is open and must be unplugged in order to stop it. Customer reported no injuries.
Patient Sequence No: 1, Text Type: D, B5
[11844968]
The cepheid smartcycler system is an integrated dna/rna amplification and detection instrument system based on the proprietary microprocessor-controlled i-core (intelligent cooling/heating optical reaction) module. The mini-centrifuge is included with the smartcycler dx system and used to spin smartcyler reaction tubes. The device is in the process of being returned to bd for evaluation. Bd will determine serial number and date of manufacture when unit is returned for investigation. Bd will file a supplemental report at the conclusion of the investigation. The device manufacturer will be notified of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2014-00005 |
| MDR Report Key | 3796416 |
| Report Source | 05 |
| Date Received | 2014-01-16 |
| Date of Report | 2014-12-16 |
| Date of Event | 2014-12-16 |
| Date Mfgr Received | 2014-12-16 |
| Date Added to Maude | 2014-05-28 |
| 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 | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | CEPHEID |
| Manufacturer Street | 904 CARIBEAN DRIVE |
| Manufacturer City | SUNNYVALE CA 94089118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94089 1189 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTCYCLER MINI-CENTRIFUGE |
| Product Code | NJR |
| Date Received | 2014-01-16 |
| Catalog Number | 441269 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CEPHEID |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-16 |