MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ABBOTT M2000SP; CLINICAL SAMPLE CONCENTRATOR

Catalog Number 09K14-02

Device Problems Charred (1086); Smoking (1585); Sparking (2595); Flare or Flash (2942)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2015

Event Type  malfunction  

Manufacturer Narrative

Elevated complaint investigation (b)(4) is in progress for this issue.An mdr follow-up report will be submitted after finalizing the complaint investigation.

Event Description

The abbott m2000 system is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories.The system is composed of the m2000rt and the m2000sp instruments.The m2000sp is intended for automated sample preparation and nucleic acid extraction prior to testing.An abbott field service engineer (fse) was at a customer site inspecting an abbott m2000sp instrument and replaced a blown dilutor fuse on the optibo circiuit board.When the fse re-initialized the instrument he saw a flash, smelled smoke, and turned off the instrument.He observed a spark between dilutors 6 and 7.The fse removed dilutors 6 and 7 and noted charring on the capacitor of the diluter 6 circuit board.There was no death or injury.It is unknown at this time if this observation was caused by an abbott product malfunction or if the device failed safely as designed.This event is reported on the basis of the potential for death or serious injury to occur if a malfunction is identified and should it recur.

Manufacturer Narrative

Summary of elevated complaint investigation (ecinv) (b)(4)-ecinv for mdr 3005248192-2015-00015 follow-up report 1: investigation into this complaint included a quality data review (device history record / batch record review and capa / non-conformance review), a product labeling review, a product evaluation, and a complaint history review to determine a product deficiency decision.Quality data review: device history record / batch record review : the material specification document was identified for the dilutor xp smart pn 10649015 to ensure there is an adequate process to receive and approve this product into inventory.A capa / non-conformance review: no records were related to this issue.Product labeling review: the m2000sp instrument system operations manual (200681-108 november 2014) was reviewed and contains appropriate safety certification information for the instrument and adequate information for troubleshooting dilutor and associated circuit board issues.The m2000sp instrument system - e-series service manual 50-608125/r4 (october 2012) was reviewed and contains adequate instructions for fse troubleshooting, part number, replacement and verification of the dilutor and associated circuit board.Product evaluation: there were no observations of charring or soot external to the dilutor metal housing.The dilutor printed circuit board (pcb) located inside the metal housing was found to be intact and a charred ceramic capacitor c27 located on the dilutor circuit board was found to have self-extinguished, as designed.Therefore, the dilutor and the m2000sp e series instrument operated as designed from a safety standpoint.The dilutor printed circuit board (pcb) was found to meet material safety standards.Ceramic capacitor c27, located on the printed circuit board, was destroyed by the failure of the printed circuit board.(b)(4).Complaint history review: (b)(4).Product deficiency decision: based on the results of the investigation elements the product conforms to safety standard iec 61010-1 and the product failed-safe per design.A product deficiency was not identified for the dilutor xp smart pn 10649015 and complaint search and spare part trending data showed no indication of any product deficiency.The dilutor printed circuit board meets material safety standards and therefore failed safe.The disposition of this complaint is unconfirmed.

• Brand Name: ABBOTT M2000SP
• Type of Device: CLINICAL SAMPLE CONCENTRATOR
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 east touhy avenue; des plaines IL 60018 3315
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 east touhy avenue; des plaines IL 60018 3315
• Manufacturer Contact: jean leete ; 1300 east touhy avenue; des plaines, IL 60018-3315 ; 2243617274
• MDR Report Key: 4936720
• MDR Text Key: 22838466
• Report Number: 3005248192-2015-00015
• Device Sequence Number: 1
• Product Code: JJH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 09K14-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1