MAUDE Adverse Event Report: CEPHEID SMARTCYCLER MINI-CENTRIFUGE

Catalog Number 441269

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: SMARTCYCLER MINI-CENTRIFUGE
• Manufacturer (Section D): CEPHEID; sunnyvale CA
• Manufacturer (Section G): CEPHEID; 904 caribean drive; sunnyvale CA 94089 118
• Manufacturer Contact: charlotte dannenfelser ; 7 loveton cir.; sparks, MD 21152 ; 4103164367
• MDR Report Key: 3796416
• MDR Text Key: 4382397
• Report Number: 1119779-2014-00005
• Device Sequence Number: 1
• Product Code: NJR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 441269
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 01/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1